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FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information

Eileen Zhou Research Associate Neuralstem Germantown, MD, United States Ezhou@neuralstem.com

Michael Channing Group Chief - Positron Emission Tomography Department NIH Bethesda, MD, United States mchanning@mail.cc.nih.gov

A B M Mahfuz ul Alam General Manager, Quality Operations ACI HealthCare Limited Dhaka, Non-US, Bangladesh mahfuz.alam@aci-bd.com

Abe Wong CCO Gmpsigma Seattle, WA, United States fdabcgmp@gmail.com

ABHIJEET GUJAR Chief Operating Officer SETHU Porvorim Goa, Non-US, India abhijeet.gujar@sethu.in

Adam Ebbinghouse QC Associate KP Pharmaceutical Technology, Inc. Bloomington, IN, United States astalder@kppt.com

Adil Gatrad Director, Quality Systems Actavis Parsippany, NJ, United States adil.gatrad@actavis.com

Adiseshu Modugula RA MSN Hyderabad, Non-US, India adiseshu123@yahoo.com

Aditiben Patel Regulatory Specialist USAMMDA Frederick, MD, United States aditiben.d.patel.ctr@mail.mil

Adriana de la Cruz Manager Laboratorios Pisa SA de CV Jalisco, Non-US, Mexico adelacruz@pisa.com.mx

ahsanul haque CSO FDA silver spring, MD, United States haque0883@gmail.com

Aimee Gogarty Quality Coordinator Mallinckrodt Port Allen, LA, United States aimee.gogarty@ikaria.com

Aislyn Fronzak QC Manager PL Developments Clinton, SC, United States afronzak@pldevelopments.com

Ajay Deshmukh QA manager Ingenus Pharmaceutical Navi mumbai, Non-US, India ajay_rising@yahoo.co.in

Ajay Khedkar Regulatory Affair Umedica Laboratories Pvt Ltd Mumbai, Non-US, India regulatory1@umedicalabs.com

Ajay Pazhayattil Associate Director Apotex Toronto, Non-US, Canada apazhaya@apotex.com

Ajay Taluja Staff Fellow FDA Silver Spring, MD, United States Ajay.Taluja@fda.hhs.gov

ajit reddy Sales mettler toledo Hyderabad, Non-US, India ajitreddy@hotmail.com

akash babber Microbiologist sgco jubail, Non-US, Saudi Arabia babber.akash@gmail.com

ALAN N[CHOLLS Sr Advisor,Regulatory Affairs COPPERHEAD CHEMICAL COMPANY INC TAMAQUA, PA, United States nicholls6@comcast.net

Albinus D'Sa Special Assistance to the Office FDA Silver Spring, MD, United States albinus.dsa@fda.hhs.gov

Alejandra Gómez Project Leader Laboratorios PiSA Guadalajara, Non-US, Mexico algomez@pisa.com.mx

Alice Hoffmann Head of Quality Assurance GMP Eurofins BioPharma Product Testing Munich GmbH Planegg/Munich, Non-US, Germany alicehoffmann@eurofins.com

Alicia Fitzpatrick EHS Regulatory Manager The Dow Chemical Company Bristol, PA, United States afitzpatrick@dow.com

Allen Che senior scientist Tetraphase Pharmaceuticals Watertown, MA, United States qche@tphase.com

Allison Aldridge Team Leader FDA Silver Spring, MD, United States Allison.Aldridge@fda.hhs.gov

allison bonnenburg Regulatory Counsel FDA Silver Spring, MD, United States bonnenburg@yahoo.com

Allison Murdza Process Development Intern Merck Lexington, MA, United States allison.murdza@merck.com

Alvin Negron Technical Consultant DGF Group San Juan, Non-US, Puerto Rico alvin.negron@dgfgroup1.com

Amanda Rennig Senior QA/QC Associate Digestive Care, Inc Easton, PA, United States arennig@digestivecare.com

Amar Edlaher Chief Compliance Officer American Pharmaceutical Ingredients, LLC Boca Raton, FL, United States aeldaher@buyapi.com

Ambrose Stafford Founder Stafford Pharma Consulting, LLC Hillsborough, NJ, United States Ambrose@staffordpharma.com

Amidhepuram Sudheer Sr. Manager Hetero drugs Hyderabad, Non-US, India sudheer.ap@heterodrugs.com

Amit Dumpawar Senior Executive Wockhardt Limited India Aurangabad, Non-US, India amit.dumpawar@gmail.com

Amy Blevins Quality & Regulatory Specialist Kenco Logistic Services, LLC Chattanooga, TN, United States amy.blevins@kencogroup.com

Amy Ganden QA & Methods Compliance, Manager Particle Technology Labs Downers Grove, IL, United States aganden@particletechlabs.com

Amy Haataja Quality Assurance Supervisor Perrigo New Hope, MN, United States Amy.haataja@perrigo.com

Ana Padilla Technician Inke, S.A. Castellbisbal, Non-US, Spain apadilla@inke.es

Anais Valencia Laboratory MAnager Henry Jackson Foundation/MHRP Silver Spring, MD, United States avalencia-micolta@hivreserch.org

Andra Bene Site Quality Engineer Celestica Romania SRL Oradea, Non-US, Romania abene@celestica.com

Andres Rivas Engineering and Projects Director Laboratorios PiSA SA de CV Guadalajara, Non-US, Mexico aarivas@pisa.com.mx

Andrew Asirvatham Quality Assurance caplin point laboratories Chennai, Non-US, India andrewasir@gmail.com

Andrew Hooper Director Commercial Manufacturing Retrophin, Inc. San Diego, CA, United States andrew.hooper@retrophin.com

Anees Moosa Retail pharmacist Private Johannesburg, Non-US, South Africa anees4877@gmail.com

anelis aurand araos Director, Scientific Affairs WellSpring Pharmaceutical Corporation Sarasota, FL, United States aaurand@wellspringpharm.com

Angela Hughes QC Manager SPI Pharma Lewes, DE, United States ahughes@spipharma.com

Angelica Rivas Quality Director MediStem Panama Inc Panama, Non-US, Panama arivas@medistemresearch.com

Angella Silye Study Manager Taro Pharmaceuticals USA Hawthorne, NY, United States angella.silye@taro.co

Anirudh Ramachandran Consultant Ernst & Young,LLP Mumbai, Non-US, India Anirudh.Ramachandran@in.ey.com

Ann Howard Reg Assoc igi labs Buena, NJ, United States annhoward@igilabs.com

Anna Long Attorney Dean, Mead, Egerton, Bloodworth, Capouano &Bozarth, P.A. Orlando, FL, United States along@deanmead.com Anne Armstrong

QA & Compliance Mgr Drug Store, Pets and Consumables Meijer, Inc. Grand Rapids, MI, United States anniem7383@yahoo.com

Anne Kuan VP Reg Neovii Waltham, MA, United States anne.kuan@neoviibiotech.com

Annette Dunn CEO Coda Corp USA Fairport, NY, United States ADunn@CodaCorpUSA.com

Annia Diggs QAQC Specialist Johns Hopkins Univ. SOM / CPGT Baltimore, MD, United States adiggs@jhmi.edu

Anshuman Saran Head CQA Strides Arcolab Limited Bangalore, Non-US, India Anshuman.Saran@stridesarco.com

Antonio Soto Handy Solutions Business Director Navajo Manufacturing Co. Inc. Denver, CO, United States asoto@navajoinc.com

Anuj Patel Quality assurance Intas pharmaceutical limited Ahmedabad, Non-US, India patelanuj89@gmail.com

Anush Perikhanyan QA Manager DarmanTest Laboratories Yerevan, Non-US, Armenia anushp@pharmatestlabs.com

April Griggs Compliance Management Unit Director WRAIR, Viral Diseases Branch Silver Spring, MD, United States april.n.griggs.ctr@mail.mil

Archana Shekher Consultant Consultant Morrisville, NC, United States ashekher27@gmail.com

Arenia Chavez assistant chemical chemist Astecal Sac Lima, PA, Peru arenia_cht@hotmail.com

Arianne Bouchard-Gagnon QA associate Nuvo Research Varennes, Non-US, Canada ariannebg@gmail.com

Arshad Ali Incharge Compliance Cell Zafa Pharmaceutical Laboratories (Pvt.) Ltd KARACHI, Non-US, Pakistan arshadalizafa.aa@gmail.com

Arthur Fabian President Fabian API Consulting LLC Parsippany, NJ, United States artfabian@fapic.net

Artur Shchukin RC Specialist AMPAK New York, NY, United States shchukin.artur@gmail.com

ARUN THANGAVELU OPERATIONS ENGINEERING SPECIALIST CELESTICA TORONTO, Non-US, Canada athangav@celestica.com

Arvind Bhalerao Director-Operations Orit Laboratories LLC West Caldwell, NJ, United States arvind@oritlabs.com

Asheley Pankratz Senior Paralegal American Pharmaceutical Ingredients, LLC Boca Raton, FL, United States apankratz@buyapi.com

Ashlee Janusziewicz Consumer Safety Officer FDA Silver Spring, MD, United States ashlee.janusziewicz@fda.hhs.gov

Ashley Boam Director (A), Ofc of Policy for Pharmaceutical Quality FDA/CDER Silver Spring, MD, United States ashley.boam@fda.hhs.gov

Ashok Kumar Boyapati Officer Raks pharma Pvt Limited Visakhapatnam, Non-US, India ashok375@rakspharma.in

Asma Ather Documentation Specialist Xttrium Laboratories Mount Prospect, IL, United States aather@xttrium.com

Atul Sakariya Corporate Quality Sun Pharmaceutical Industries Limited Vadodara, Non-US, India atulrx235@gmail.com

Audrey Zaweski President Peconic Regulatory Consulting LLC Calverton, NY, United States azaweski@peconicregulatoryconsultingllc.net Aurelis Cosme

Chemist- Quality Control Gasco Industrial Gurabo, Non-US, Puerto Rico acosme@gascoindustrial.com

Avia Toney Vice President of Quality Assurance and Regulatory Affairs GeNO LLC Cocoa, FL, United States Avia.Toney@genollc.com

B R Reddy Director-Operations Natco Pharma Ltd Hyderabad, Non-US, India brreddy@natcopharma.co.in

Baban Bhalerao Sr. Officer EnEm Nostrum Remedies Pvt. Ltd. Mumbai, Non-US, India bhaleraobaban@gmail.com

Babu Lad Dir. Regulatory Affairs Pharmaceuticals Parsippany, NJ, United States blad@validuspharma.com

Bahrudin Kapo QAS Supervisor Belcher Pharmaceutical Largo, FL, United States bkapo@belcherpharma.com

bala kumar Associate - Regulatory Affairs Shasun Pharmaceuticals Limited Puducherry, Non-US, India balakumara@shasun.com

Bala Nagisetti QA-Manager Sciegen Pharmaceuticals Inc Hauppauge, NY, United States balamuralin@sciegenpharm.com

balakrishna Nunna Dy. Manager -RA Bioplus lifesciences pvt limited bangalore, KS, India ra.eu1@bioplus.in

Bangon Longsomboon Regulatory Manager University of Miami, Miller School of Medicine Miami, FL, United States b.longsomboon@med.miami.edu

Barbara Hach QA Manager Cosmax USA Solon, MA, United States barb.hach@cosmaxusa.com

Barbara Thorne Executive Director Pr Dev. Celladon Seattle, WA, United States bthorne@celladon.com

Barry Goodwin COO ONY, Inc. Amherst, NY, United States bgoodwin@onyinc.com

Becky Nortz Associate Director, Regulatory Affairs New Haven Pharmaceuticals North Haven, CT, United States bnortz@newhavenpharma.com

Ben LU VP, Quality Sagent China Pharmaceuticals Chengdu, Non-US, China bent61@me.com

Benjamin Cordova Chemist Thibiant Internationl Chatsworth, CA, United States bcordova@thibiant.com

Benjamin Do Regulatory Affairs Coordinator Diamond Wipes International Chino, CA, United States bdo@diamondwipes.com

Benjamin Kraus Auditor for Medical Devices Strauss Medizintechnik Bochum, Non-US, Germany gmp.compliance@outlook.com

Benjamin Stevens Chemistry Reviewer FDA White Oak, MD, United States benjamin.stevens@fda.hhs.gov

Bernadette De Leye Quality Excellence Coach STEXCON Haasrode, Non-US, Belgium bdl@stexcon.be

Beth Carr Pharmacist FDA/CDER Silver Spring, MD, United States beth.carr@fda.hhs.gov

Betty Jo Lorenz VP, Quality & Regulatory Bell Pharmaceuticals, Inc. Belle Plaine, MN, United States bettyjo@bellpharm.com

BETTY LLANA Inspector GMP MINISTRY OF HEALTH DIGEMID PERU LIMA, Non-US, Peru boabechy@hotmail.com

Beverly Folmer Manager, Pharmaceutical Development Incyte Germantown, MD, United States bfolmer@incyte.com

Bhagwan Chaudahry Research Analyst Sunidhi Securities Mumbai, Non-US, India bhagwan.c@sunidhi.com

Bhagyashree Bhargave Senior Group Leader Strides Arcolab Limited Bangalore, Non-US, India bhargaveb@yahoo.com

Bhim Bahadur Chaudhari Research UIPS,Panjab University chandigarh, Non-US, India chaudhari_bhim@yahoo.com

bipin kumar Audit and Compliance wockhardt Aurangabad, Non-US, India bipink@wockhardt.com

bipin kumar Audit and Compliance wockhardt Aurangabad, Non-US, India bkumar@wockhardt.com

Blanca Zabala Pharmacy staff N/A Miami, FL, United States brzabal226@gmail.com

Bob MacDonald Vice President, Regulatory Affairs Scientific & Regulatory Consultants, Inc. Columbia City, IN, United States bmacdonald@srcconsultants.com

Bobae Kim VP Quality, Regulatory, Clinical Affairs Iluminage Beauty Inc. New York, NY, Canada bkim@iluminagebeauty.com

Brandi Adoff Director Regulatory Affairs Vensun Yardley, PA, United States badoff@vensunrx.com

Brian Mabie Pharmacist-in-Charge American Pharmaceutical Ingredients, LLC Waterford, MI, United States bmabie@buyapi.com

Brian Newton Head of Risk & Regulatory Affairs PROTein Biotechnologies Inc Ramona, CA, United States bk.newton09@gmail.com

Brittany Ann Medeo Compliance Consultant QACV Consulting Bethlehem, PA, United States brittany.medeo@qacvconsulting.com

Brooke Yakatan Director, QA & Regulatory IriSys LLC San Diego, CA, United States byakatan@irisys.com

Caprice Bearden Director of Compliance Pharmakon Pharmaceuticals Noblesville, IN, United States cbearden@pharmakonrx.net

Caption Colorado Captioner Caption Colorado Greenwood Village, CO, United States patrickgtz@aol.com

Carla Silva RA analyst Aché Laboratórios Farmacêuticos Guarulhos, Non-US, Brazil carlasilva.unifesp@gmail.com

Carlos Amaro Technical Director Inmed Per{u S.A.C. Lima, Non-US, Peru carl_amaro@yahoo.es

Carlos Martin Mayma A. Regulatory assesor DIGEMID LIMA, Non-US, Peru cmayma@digemid.minsa.gob.pe

Carlos Montoyo Senior Consultant DGF Group San Juan, Non-US, Puerto Rico carlos.montoyo@dgfgroup1.com

Carlton Rhames QA Supervisor Capstone Nutrition Spring Hill, TN, United States crhames@capstonenutrition.com

Carmen Kelly Consumer Safety Officer FDA Silver Spring, MD, United States carmen.kelly@fda.hhs.gov

Carmen Janneth Rivera Palacin Químico Farmaceutico Drección General de Medicamentos, Insumos y Drogas DIGEMID Lima, Non-US, Peru crivera@digemid.minsa.gob.pe

Carol Marchione VP, Reg Affairs and QA TetraLogic Pharmaceuticals Malvern, PA, United States carol.marchione@tlog.com

Carolina Geraldo Assessor Farmacêutico Aché Laboratórios Farmacêuticos S.A. São Paulo, Non-US, Brazil carolina.geraldo@ache.com.br

Catherine Johnson HLS Regulatory Lead WIpro Highland Park, IL, United States catherine.johnson@wipro.com

Catherine Mastrorilli Assistant Scientist Janssen R&D Malvern, PA, United States cszuba@its.jnj.com

Catrina Montgomery GCP Coordinator Romark Labortories Tampa, FL, United States Catrina.montgomery@romark.com

Celeste Goddard Regulatory Affairs Specialist Merz North America Raleigh, NC, United States celeste.goddard@merz.com

Celia Hernandez Manager Laboratorios Pisa SA de CV Jalisco, Non-US, Mexico chernandez@pisa.com.mx

Cesar Burgos QC Tech SHL Pharma Boca Raton, FL, United States cesar799@gmail.com

Chakrapani Kambhampati MANAGER MYLAN VISAKHAPATNAM, Non-US, India chakrapani.kambhampati@mylan.in

chander kazipeta Head - Global Regulatory Affairs airis PHARMA Hyderabad, Non-US, India kchander@airispharma.com

CHANDRA SHEKAR GUMPALLY Assistant Manager Dr.Reddys Laboratories Limited Hyderabad, Non-US, India chandumphbits@gmail.com

chandrasahker akula Manager Validation AMRI Albany, NY, United States chandrashaker.akula@amriglobal.com

Chang Lee Sr. Dir, RA/CA Capsugel Morristown, NJ, United States chang.q.lee@capsugel.com

changguang wang scientist UTSW DALLAS, TX, United States chg-wang@hotmail.com

Chantal Joly quality specialist (consultant) Telesta Therapeutics Inc. Pointe-Claire, Non-US, Canada cjoly@laporteconsultants.com

Chantal Pare QA Manager Nuvo Research Inc. Varennes, Non-US, Canada cpare@nuvoresearch.com

Charan Behl Manager PAC Pharmaceuticals, LLC Far Rockaway, NY, United States crbehl@aol.com

Charles Celeste Director, Regulatory Pollicy & Intell Leo Pharma Parsippany, NJ, United States chris.celeste@leo-pharma.com

Charles DiTusa Quality Assurance USAMMDA Ft. Detrick, MD, United States charles.a.ditusa.mil@mail.mil

Chaudhry Tajammal Hussain Quality Systems and Standards Lead Novartis Pharma Karachi, Non-US, Pakistan tajammal.s.hussain@hotmail.com

Chee Kean Ong Senior QRA Manager Celestica Malaysia Sdn. Bhd. Kulim, Non-US, Malaysia ockean@celestica.com

Chelsea Cabral chemist Queen's Medical Center Honolulu, HI, United States ccabral@queens.org

Chethan Jungir research and development Biocon research labs Bangalore, Non-US, India chethanjungir@gmail.com

Chi Vo R&D Manager Nuvo Research Inc. Varennes, Non-US, Canada cvo@nuvoresearch.com

chong kim CMC Reviewer OLDP/OPQ/CDER Silver Spring, MD, United States chongho.kim@fda.hhs.gov

Chris Fowler Member Chris Fowler, LLC Newtown, CT, United States Cfowler@consultcf.com

Chris Goodpaster Quality Control Microbiologist ISTO Technologies Ollivette, MO, United States cgoodpaster@istotech.com

Chris Holshouser Owner GH Quality Consulting Wilmington, NC, United States holshouser@gmail.com

Chris Jacques Sr. Manager Corium International, Inc. Grand Rapids, MI, United States chrisj@coriumintl.com

Chris Wubbolt President & CEO QACV Consulting, LLC Bethlehem, PA, United States chris.wubbolt@qacvconsulting.com

Christina Thompson QA Alvix Laboratories Ocean Springs, MS, United States CThompson@alvix.com

Christine Hendricks Quality Assurance Group Leader Consumer Product Testing Company Fairfield, NJ, United States CHendricks@cptclabs.com

Christine Miller VP Regulatory Affairs TherapeuticsMD Boca Raton, FL, United States christine.miller@therapeuticsmd.com

Christopher Smith President Coastal Pharmaceutical Consultants, Inc. Burgaw, NC, United States chrissmith@coastalpharmaconsultants.com

Chunli Zhao QA Director Asychem Lab. Tianjin, Non-US, China zhaochunli@asymchem.com.cn

Cici Lu RA Yaopharma Co., Ltd. Chongqing, Non-US, China lucy@yaopharma.com

Cindy Lumbert Quality Compliance Manager Lakeshore Technologies Norton Shores, MI, United States clumbert@lakeshoretechnologies.com

Cindy Martin Director, Regulatory Affairs Aerie Pharmaceuticals, Inc. Irvine, CA, United States cmartin@aeriepharma.com

Cinzia Romero Pharmacist MINSA PERU Lima, Non-US, Peru cinziaofelia@gmail.com

Claire German Project Coordinator FDA Rockville, MD, United States claire.german@fda.hhs.gov

Colleen Johns Regulatory Affairs Sancilio and Company Riviera Beach, FL, United States cjohns@sancilio.com

congbiao mei senior group leader united therapeutics silver spring, MD, United States cmei@unither.com

CONSUELO LI PHARMACIST EVALUATOR DIGEMID lima, Non-US, Peru colising05@hotmail.com

Corrine Knight Director of Business Initiatives Coda Corp USA Fairport, NY, United States CKnight@CodaCorpUSA.com

Creighton Tuzon Research Associate USC Los Angeles, CA, United States tuzon@usc.edu

Cris Lebrilla Director of Quality Assurance C3 Jian, Inc. Marina del Rey, CA, United States clebrilla@c3-jian.com

Crystal Gabriel Sr Process Tech SHL-Group Deerfield Beach, FL, United States crystal.gabriel@shl-group.com

Dale Allen Associate Director Dynport Vaccine Company, CSC-GS Frederick, MD, United States dallen56@csc.com

Dan Bigman VP of Quality Gasco Industrial Gurabo, Non-US, Puerto Rico dbigman@gascoindustrial.com

Dan Wunderlich Director QA/RA WellSpring Pharmaceutical Canada Oakville, Non-US, Canada dwunderlich@wellspringpharm.ca

Daneris Fernandez CEO DGF Group San Juan, Non-US, Puerto Rico daneris.fernandez@dgfgroup1.com

Daniel Gastelu President Health Product Business Success LLC Sparta, NJ, United States dan@supplementfacts.com

Daniel Kashiwagi Researcher Prati-Donaduzzi Toledo, Non-US, Brazil daniel.kashiwagi@pratidonaduzzi.com.br

Darrin Hofer Compliance Manager Conair Corporation Rantoul, IL, United States darrin_hofer@conair.com

DARSHAN THAKKAR REGULATORY OFFICER sTEPUP PHARAMATECH AHMEDABAD, Non-US, India darshanthakkar111@gmail.com

datta tupepatil manager UMEDICA LABORATORIES PVT LTD mumbai, IN, India dattatupepatil@umedicalabs.com

David Hernandez Director, Regulatory Affairs Chemo Group Chatham, NJ, United States dhernandez@chemogroup.net

David Jara QA Associate Xttrium Labs Mt. Prospect, IL, United States djara@xttrium.com

David Beristain Manager Proquina/Bayer Orizaba, Non-US, Mexico david.beristain@bayer.com

David Ferch Operations Manager Valjean Corporation Indian Harbour Beach, FL, United States david.ferch@cfl.rr.com

David Kuchta QA Mgr. QuadPharma LLC Clarence, NY, United States dkuchta@qdpharma.com

David Lin Senior Consultant Biologics Consulting Group Potomac, MD, United States Dlin@bcg-usa.com

david mcfarland editor fda webview camp hill, PA, United States david@fdaweb.com

David Meredith Quality Supervisor Kenco Logistics Chattanooga, TN, United States david.meredith@kencogroup.com

David Pereira Director of Operations Afton Scientific / AnovaFill Charlottesville, VA, United States dpereira@aftonscientific.com

David Swain Vice President, Regulatory Affairs Scientific & Regulatory Consultants, Inc. Columbia City, IN, United States dswain@srcconsultants.com

david zhao Sr. VP Prinbury Biopharm Pudong, Non-US, China david.zhao@prinburybiopharm.com

Davina Marano Regulatory Counsel FDA/CDER/OC Silver Spring, MD, United States davina.marano@fda.hhs.gov

dawn spooner regulatory affairs perkinelmer waltham, MA, United States dawn.spooner@perkinelmer.com

Deana Kaye President and Principal Medical Writer II DBL Clinical Associates, Inc. Durham, NC, United States deanabkaye@gmail.com

Debaleena Bandopadhyay Regulatory Associate Astex Pharmaceuticals Pleasanton, CA, United States debaleena.bandopadhyay@astx.com

Debashis Chakraborty Manager-QA Raks Pharma Pvt.Ltd. Visakhapatnam, Non-US, India debashisc@rakspharma.com

Debashish Panda Head Quality Naprod Life Sciences Mumbai, Non-US, India debashish.panda@naprodgroup.com

Debbie Gumpert Regulatory Specialist II Albemarle Corporation South, MI, United States debbie.gumpert@albemarle.com

debolina sen roy student pes college of pharmacy bengaluru, Non-US, India widbestwishesdebz@gmail.com

Deborah Formelio Clinical Quality Manager Romark Laboratories, L.C. Tampa, FL, United States Deb.Formelio@romark.com

Debra Dow President Dow Development Laboratories, LLC Petaluma, CA, United States ddow@dowdevelopmentlabs.com

Debra Lehnus QA/Regulatory Manager Prestige Packaging Fort Myers, FL, United States dlehnus@prestigepackaging.net

Delaram Moshkelani Review Chemist FDA Silver Spring, MD, United States delaram.moshkelani@fda.hhs.gov

Delphine MERCIER Quality team member MEDINCELL Jacou, Non-US, France delphine.mercier@medincell.eu

Denis Seungryum Kim Intellectual Property Associate Celltrion Pharm Cheong Ju, Non-US, South Korea seungryum.kim@celltrionph.com

Denise Ekstrom RA Manager DVC Frederick, MD, United States dekstrom@csc.com

Dequan Zhu Operation Director Shuang Bei Medical Group Tianjin, Non-US, China aaronchuh@chinassp.net

DERAJRAM BENIVAL Manager (Corporate R & D) HLL Lifecare Limited Trivendrum, Non-US, India benivalderaj@gmail.com

Derry Spragion Scientist Catalent Pharma Solutions Morrisville, NC, United States derry.spragion@catalent.com

devender Malhotra Sr.Executive Solrex Pharmaceuticals Company baddi, Non-US, India devenderkumar.malhotra@sunpharma.com Devendra Chavan

Senior Research Scientist Colgate Palmolive India Limited Mumbai, Non-US, India devendrachavan@yahoo.com

DHARMESH PATEL Head Regulatory Affairs Atul Limited Valsad, Non-US, India dharmesh_ppatel@atul.co.in

Dhiren Bhatt Deputy General Manager Wockhardt Ltd. Aurangabad, Non-US, India dbhatt@wockhardt.com

Diallo Mamadou President Diallo Global CMC Attleboro, MA, United States mtahiroud@msn.com

Diana Baronian Sr. Quality Specialist Guthy|Renker LLC Santa Monica, CA, United States dbaronian@guthy-renker.com

Diana Lozano QA Compliance Gilead Sciences, Inc. San Dimas, CA, United States diana.lozano@gilead.com

Diana Parra Student Student Pittsburgh, PA, United States daparraf@gmail.com

Dilip Parikh President DPHARMA GROUP INC. ELLICOTT CITY, MD, United States dpharma@gmail.com

Dimple Bommanaboina Regulatory Affairs Citron Pharma LLC East Brunswick, NJ, United States dimple@citronpharma.com

Dinesh Kumar Regulatory Counsel FDA Silver Spring, MD, United States dinesh.kumar@fda.hhs.gov

Dipa Ramolia Sr. Manager, Quality LEO Pharma Inc. Parssippany, NJ, United States dipa.ramolia@leo-pharma.com

Dipenkumar Patel Senior Associate, Regulatory Affairs Granules USA, Inc. Parsippany, NJ, United States dipen.patel@granulesindia.com

Dnyaneshwar Gawade Manager Training & Developement Sun Pharmaceutical Industries Ltd. Dewas, Non-US, India dnyaneshwar.gawade@sunpharma.com

Dominick DiPaolo SVP Quality, Compliance & Regulatory Tris Pharma Monmouth Junction, NJ, United States ddipaolo@trispharma.com

Donato Barbato Researcher Advanced accelerator applications Turin, Non-US, Italy donato.barbato@adacap.com

Donna Brandt Quality Control Manager Cosmetic Laboratories of America Chatsworth, CA, United States dbrandt@cla-cosmeticlabs.com

Donna Roney Manager Pfizer Richmond, VA, United States donna.roney@pfizer.com

Dorcas Taylor Consumer Safety Officer FDA Silver Spring, MD, United States dorcas.taylor@fda.hhs.gov

Doris Ng Regional Quality System Manager Celestica Asia Singapore, Non-US, Singapore mleng@celestica.com

Doris Ogrowsky Consultant Regylatory Specialists St. Louis, MO, United States ogrowsky@aol.com

Dorothea Murray Director of Chemical Research and Product Analysis American Pharmaceutical Ingredients Boca Raton, FL, United States dmurray@buyapi.com Dorothy Guidry

Director of Quality Capstone Nutrition-TN Spring Hill, TN, United States dguidry@capstonenutrition.com

Doug Shaw Director of CSV & IT Consulting Azzur Group Annapolis, MD, United States doug.shaw@azzur.com

Douglas Kline Principal Douglas Kline UG (haftungsbeschraenkt) Berlin, Non-US, Germany doug@douglasklineug.de

Dr. Matthias Grathwohl Head of Quality Management Swiss Caps AG Kirchberg, Non-US, Switzerland matthias.grathwohl@aenova-group.com

Dragana Males Medical Director ADAMIS PHARMACEUTICALS CORPORATION San Diego, CA, United States dmales@adamispharma.com

Dumbala Shashikanth Reddy Quality Manager Zhejiang Jiuzhou Pharmaceuticals Ltd Taizhou, Non-US, China reddy_shashikanth@yahoo.com

Durgaprasad Erukulla Officer-Regulatory affairs Mylan hyderabad, Non-US, India Durgaprasad.Erukulla@mylan.in

Dwight Edghill QA Lead Horizon Pharmaceuticals' Inc. Riviera Beach, FL, United States dake2k@hotmail.com

Eberth Leopoldo Sarmiento Infantes EVALUATOR DIRECCIÓN GENERAL DE MEDICAMENTOS INSUMOS Y DROGAS DEL PERÚ LIMA, Non-US, Peru esarmiento@digemid.minsa.gob.pe Eddie Liu

TS senior director Sunny pharmtech Taoyuan, Non-US, Taiwan eddie.liu@sunnypharmtech.com

Edmund Mickunas Principal Consutant Regulatory Consulting Centerville, MA, United States emickunas@yahoo.com

Eduardo Maldonado Principal Officer EM Consulting Group Guaynabo, Non-US, Puerto Rico eduardomaldonado@mac.com

Edward Patt Principal Consultant Edward Patt LLC Lenoir, NC, United States ed.patt@gmail.com

EDWIN ESPINOZA GUTIERREZ PHARMACIST DIGEMID LIMA, Non-US, Peru irvin8427@hotmail.com

Eileen Castillo QC Manager A.I.G. Technologies, Inc Deerfield Beach, FL, United States eileen@aigtechnologies.net

Eileen Daloia Director Regulatory Affairs Crown Laboratories Johnson City, TN, United States edaloia@crownlaboratories.com

Elaine Scheye President The Scheye Group Ltd. Chicago, IL, United States escheye@gmail.com

Elangho Muthusamy Specialist Senior Registrar Rashid Hospital Dubai, Non-US, United Arab Emirates uma_elangho@yahoo.co.in

Elena Violeta Mendoza Arevalo ASISTENTE Ministerio de Salud PERU-DIGEMID LIMA, Non-US, Peru elenavioleta@gmail.com

Elina N. Khachiyan Regulatory Compliance Specialist AIC Framingham, MA, United States ekhachiyan@aicma.com

Elisa Perdon Quality Assurance Directorf US Pharmaceutical Corporation Decatur, GA, United States e.perdon@uspco.com

Elizabeth Jumet Vice President Keystone Laboratories Memphis, TN, United States emenkejumet@keystone-labs.com

Elizabeth Mason Manager, Regulatory Affairs Haemonetics Corporation Covina, CA, United States elizabeth.mason@haemonetics.com

Elizabeth Moyer CEO M/P Biomedical Consultants LLC Mill Valley, CA, United States moyer@mpbiomed.com

Elizabeth Noble owner/consultant Elizabeth P. Noble, Inc. Salisbury, NC, United States elizabethpnobleinc@carolina.rr.com

Elizabeth Rita Gutierrez Valencia Practicing Universidad Nacional Mayor de San Marcos Lima, Non-US, Peru eligutval20@gmail.com

Elle Bard Paralegal HTC LLC South Lyon, MI, United States elleb4@gmail.com

Ellen Camos Director ANI Pharmaceuticals Raleigh, NC, United States ellen.camos@anipharmaceuticals.com

Ellen Lindner Sr. Regulatory Affairs Specialist University of Pennsylvania Philadelphia, PA, United States elindner@upenn.edu

Emily Tash QA Manager Precision Nuclear Salem, VA, United States etash@precisionnuclearllc.com

enrique pernas Manager ARD avevadds Miramar, FL, United States enrique.pernas@avevadds.com

Eoin Walsh Director of Analytical Sciences Coda Corp USA Buffalo/Niagara, NY, United States Ewalsh@CodaCorpUSA.com

Eric Song Quality Director Sagent pharmaceuticas (China) Pharmaceuticals Co., Ltd. Chngdu, Non-US, China qsong@sagentchina.com Eric White

Sr. VP Regulatory Affairs Mission Pharmacal Company Boerne, TX, United States eric.white@missionpharmacal.com

Erica Weiss Administrative Assistant American Pharmaceutical Ingredients, LLC Boca Raton, FL, United States eweiss@buyapi.com

Erika Guzmán QA System Manager WellSpring Pharmaceuticals Sarasota, FL, United States eguzman@wellspringpharm.com

Erin Achurch MQA Specialist Pfizer Saint Louis, MO, United States ela101687@gmail.com

Esther Sur QA/RA Coordinator Iluminage Beauty Inc. New York, NY, United States esur@iluminagebeauty.com

EunSeon Yang Assistant manager Penmix Ltd. Seoul, Non-US, South Korea esyang04@gmail.com

Eva Kabir Chairperson BRAC university Dhaka, Non-US, Bangladesh eva.kabir@gmail.com

Evangeline Raguindin R&D/Regulatory Affairs Manager Diamond Wipes International, Inc. Chino, CA, United States eraguindin@diamondwipes.com

Evin Aycicek Durak R&D Senior Specialist Researcher Biofarma Pharmaceutics Istanbul, Non-US, Turkey evin.aycicek@biofarma.com.tr

Farishta Barack Researcher Maryland Baltimore, MD, United States Researcher2009@gmail.com

Farzad Parsaie Chief Operating Officer, GeNO LLC Cocoa, FL, United States Farzad.Parsaie@genollc.com

Fatih Karademir Quality Assurance Manager ARGIS Ilac Co. Ankara, Non-US, Turkey fatihkarademir@argisilac.com.tr

Fei Cheng Regulatory Affairs Yiling Pharmaceutical Ltd Shijiazhuang, Non-US, China fei.cheng@yiling.cn

feifei liu QA engineering Luye pharmaceutical Yantai, Non-US, China lff19870708@hotmail.com

Felix Morales Quality Assurance Supervisor Navajo Manufacturing Co. Inc. Denver, CO, United States fmorales@navajoinc.com

FERNANDO VILCHEZ pharmacist sisol peru, PA, Peru fvt2002@hotmail.com

Fiona Gould Regulatory Affairs Project Manager Quotient Edinburgh, Non-US, United Kingdom fiona.gould@quotientbd.com

Forest Ford CSO FDA Silver Spring, MD, United States forest.ford@fda.hhs.gov

Frances King QA Manager TopChem Pharmaceuticals Sligo, Non-US, Ireland frances@topchempharma.com

Francesca Knowles Quality Specialist Coda Corp USA Buffalo/Niagara, NY, United States Fknowles@CodaCorpUSA.com

Francesca Minale President AF Pharma Inc. Piscataway, NJ, United States francesca.minale@afpharmainc.com

Francisco Huerta Manager Laboratorios PISA SA de CV Guadalajara, Non-US, Mexico fhuerta@pisa.com.mx

Francois Perreault lab supervisor - chemistry Galderma Montreal, Non-US, Canada francois.perreault@galderma.com

francy elguera area manager Medikids Lima, Non-US, Peru qffrancyelguera@gmail.com

FRANK PERRELLA Project Manager FDA/CDER Silver Spring, MD, United States Frank.Perrella@FDA.HHS.GOV

Frantiescoli Dimer Formulation Researcher Instituto Vita Nova Hortolandia SP, Non-US, Brazil frantiescoli.dimer@institutovitanova.org.br

fray huamanyauri DRA Jr Coordinator Peru GSK Consummer Health Care Lima, Non-US, Peru frayhuamanyauri@gmail.com

frederick golec president cmcregaff, llc merion station, PA, United States golec@CMCRegAff.com

frederick morgan none lianyungang runzhong pharmaceutical co.ltd

lianyungang，jiangsu，china, Non-US, China 1984520399@qq.com

Frederick Simon Golec Jr PhD RAC President CMCRegAff, LLC merion station, PA, United States simong1326@gmail.com

Frida Alcala Manager Laboratorios PISA SA de CV Guadalajara, Non-US, Mexico fgalcala@pisa.com.mx

Gabriel Kaddu Senior GMP Specialist USP ROCKVILLE, MD, United States gkk@usp.org

Gabriel Lebovic Vice President of Regulatory Affairs Global Regulatory Consulting, Ltd. Warminster, PA, United States GLEBOVIC001@COMCAST.NET

Gabriela Miranda Orr Consultant Regulatory Affairs External Consultant Minneapolis, MN, United States gabrielamirandaorr@hotmail.com

Gale Dykes Director of Security Endo Pharmaceutical Rye, NY, United States dykes.gale@endo.com

Gamal Aberra Sr Manager, Fermentation/Purification DVC Vaccine LLC Frederick, MD, United States gaberra@csc.com

gaurav thakur officer dpcl ahmedabad, Non-US, India gdbits18@gmail.com

gaus khan senior vice president Abon pharmaceuticals LLC northvale, NJ, United States gaus.khan@abonpharma.com

Geeta Routray Manager-Corporate Regulatory Affairs Piramal Enterprises Limited Mumbai, Non-US, India geeta.routray@piramal.com

Geetanjali Jaguste Sr. Manager Regulatory Affairs Lupin Pharmaceuticals Inc Baltimore, MD, United States gjaguste@lupinusa.com

George Chang Pharmacologist FDA Silver Spring, MD, United States chingjey.chang@fda.hhs.gov

George Cobos QC Manager Paramount Cosmetics, Inc. Clifton, NJ, United States georgec@paramountcosmetics.net

George Efthyvoulos QC Manager GR Foothill Ranch, CA, United States gefthyvoulos@guthy-renker.com

George Waterhouse President BioPharm Compliance, Inc Dunn, NC, United States waterhouse@biopharmcompliance.com

Georgina Lo GxP Compliance Manager BioMarin Pharmaceuticals Novato, CA, United States glo@bmrn.com

Gina Guido-Redden COO Coda Corp USA Buffalo/Niagara, NY, United States GGuidoRedden@CodaCorpUSA.com

GINA ROEBKE EXECUTIVE ASSISTANT LNK INTERNATIONAL, INC. HAUPPAUGE, NY, United States GROEBKE@LNKINTL.COM

Giridhar Prasad Jangly Regulatory Affairs Associate Dr. Reddy's Laboratories Inc. Princeton, NJ, United States gjangly@drreddys.com

Girish Koni Chemist Guardian Drug Company Dayton, NJ, United States konigirish@yahoo.co.in

Gladys Martin Regulatory Affairs Manager Romark Laboratories, LC Tampa, FL, United States gladys.martin@romark.com

Glenn Huang Principal Scientist Icon Bioscience, Inc. Sunnyvale, CA, United States glennhuang@hotmail.com

gonzalo carranza pharmacist digemid Lima, Non-US, Peru gonzzapp@yahoo.com

GOPAL PATEL Regulatory Affairs Specialist Navinta LLC Ewing, NJ, United States gopal.patel@navinta.com

Govindaswamy Periyannan Group leader Corporate quality assurance Advinus Therapeutics Ltd. Bengaluru, Non-US, India kptmgovind@yahoo.com

Gregory Pollieri Manufacturing Engineer Intern Celestica Inc. Toronto, Non-US, Canada gregpol@celestica.com

Gregroy Burke Self employed GBB, LLC Saint Louis, MO, United States gburke@live.com

Gunjan Vanarase Sr. Manager, Corporate Quality and Compliance G&W Laboratories, Inc South Plainfield, NJ, United States gvanarase@gwlabs.com Guravaiah Nalajam

Manager Hisun Pharmaceutical ltd Taizhou, Non-US, China guruchem83@yahoo.com

habibeh mahboobi RPH howard university hospital McLean, NV, United States hm1220@yahoo.com

Hammad Ali Officer Regulatory Affairs PharmEvo Pvt. Ltd. Karachi, Non-US, Pakistan hammad.ali@pharmevo.biz

Hana Boudiaf Regulatory Affairs Medincell Cambridge, MA, United States hana.boudiaf@medincell.eu

Harikishan Komma Head _ Regulatory Affairs Caplin Point Laboratories Limited Chennai, Non-US, India harikishan@caplinpoint.net

Harish Cherivirala Sr. Manager Abon Pharmaceuticals Northvale, NY, United States harish.cherivirala@abonpharma.com

harish varma Formulation scientist appcurelabs Hyderabad, Non-US, India harishvarma.p@outlook.com

Harshitha Talluri Regulatory Affairs Associate Appco Pharma somerset, NJ, United States harshita.talluri@appcopharma.com

Heather Dillon Quality Training Specialist Romark Laboratories, L.C. Tampa, FL, United States heather.dillon@romark.com

Heather Gingerich Regulatory Affairs Associate Sun Pharmaceutical Industries, Inc. Bryan, IN, United States heather.gingerich@sunpharma.com

Heather Pratt Manager, Regulatory & Clinical Affairs Macopharma Duluth, GA, United States heather@macopharmausa.com

Heemin Rhee President Health Research International North Potomac, MD, United States rheehm41@gmail.com

Heeyoung Park Sr. Manager, Regulatory Affairs Turing Pharmaceuticals New York, NY, United States heeyoung@turingpharma.com

Helen Hao Regulatory Affairs Manager CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China helenhao2005@vip.qq.com

Helen Sun Associate Director, Regulatory Affairs Bausch Bridgewater, NJ, United States helen.sun@bausch.com

Helen Zhang DMF Specialist Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd Hangzhou, Zhejiang, China, Non-US, China sunnywood_zhang@163.com

Hemant Wedhane Asst. Manager Ajanta Pharma Ltd Bharuch, Non-US, India hemant.wedhane@ajantapharma.com

Henry Lapoint Operations Manager Astecal Lima, Non-US, Peru henrylapoint@astecal.com.pe

Hezuo Zhao QA Supervisor BrightGene Pharmaceutical Co.,Ltd. Suzhou, Non-US, China validationzhao@126.com

Himanshu Jain QA Manager, PDS Contract Pharmaceuticals Limited Canada Mississauga, Non-US, Canada hjain@cplltd.com

Hippolitus Odukwu Director of QA & Regulatory Affairs Angelini Pharma Inc. Gaithersburg, MD, United States hodukwu@angelini-us.com

Hira Shariq Sr. Executive Quality Control Getz Pharma Karachi, Non-US, Pakistan drshary@hotmail.com

hira shariq Sr. Executive QC Getz Pharma Karachi, Non-US, Pakistan hirawaqar2003@yahoo.com

hiren patel QUALITY ASSOCIATE kashiv pharma BRIDGEWATER, NJ, United States hirenkumarp@kashivpharma.com

Hiren Shah General Manager Wockhardt ltd Ankleshwar, Non-US, India hirenshah@wockhardt.com

hirenkumar sonani Sr. Scientist I Kashiv Pharma LLC Bridgewater, NJ, United States hpatel85@live.com

Hirofumi Kawai Manager Kyowa Hakko Kirin Pharma, Inc. Princeton, NJ, United States hkawai@kyowa-kirin-pharma.com

Hong Chen vp of R&D Yiling Pharmaceutical shijiazhuang, Non-US, China chen8591@yahoo.com

Hongfei Yue chemist FDA silver spring, MD, United States hongfei.yue@fda.hhs.gov

Hongmei Li reviewer FDA/CDER Silver spring, MD, United States Hongmei.li@fda.hhs.gov

Hu Haining Associate Gilead Shanghai, Non-US, China huhaining_nju@126.com

hui zhang RA officer Beijing Yiling Bio-engineering Technology Co., Ltd Beijing, Non-US, China zhanghui19890328@126.com

Ian Hardy CMC Director TetraLogic Pharmaceuticals Malvern, PA, United States ian.hardy@tetralogicpharma.com

Ilango Thangavelu Functional Test developer Celestica Toronto, Non-US, Canada ithangav@celestica.com

Imtiyaz Ubharay Manager R&D-QA Tris Pharma Inc. Monmouth Junction, NJ, United States iubharay@trispharma.com

Inigo Pfeiffer Director Pharma & Biomed AmRuss Kernersville, NC, United States ipfeiffer@outlook.com

Inna Strakovsky Sr. Regulatory Affairs Specialist University of Pennsylvania Philadelphia, PA, United States innastr@upenn.edu

Irene Banas Regulatory Manager Delaval Manufacturing Bannockburn, IL, United States irene.banas@delaval.com

Irene Ng QA Manager Celestica Electronics (M) Johor Sdn Bhd Johor, Non-US, Malaysia irenepng@celestica.com

Irene Rao QRA Specilaist Stanford Blood Center Palo Alto, CA, United States irenerao@stanford.edu

Isabel Cisneros Regulatory Affairs RGR Pharma Ltd Windsor, Non-US, Canada Isabel@rgrpharma.com

Isabella Schmitt Regulatory Affairs Associate Repros Therapeutics The Woodlands, TX, United States ischmitt@reprosrx.com

Ismahan Ugas Clinical Trial Administrator NCI Rockville, MD, United States ugasi@mail.nih.gov

Izabela Rejdych Regulatory Affairs Manager AAA Saint Genis Pouilly, Non-US, France izabela.rejdych@adacap.com

Jabid Lotero Regulatory Affairs Anakyst Procaps S.A Barranquilla, Non-US, Colombia jlotero@procaps.com.co

Jack Zheng Regulatory Affairs Ruby Pharma Duluth, GA, United States zyls69@gmail.com

Jacki O'Leary Regulatory Affairs Specialist Ocular Therapeutix Bedford, MA, United States joleary@ocutx.com

Jacob Berns Manager, Technical Affairs Interchem Corp Paramus, NJ, United States jberns@interchem.com

Jacob Wendling Training Coordinator SPI Pharma Grand Haven, MI, United States jwendling@spipharma.com

jacqueline crawford Manager, Quality Systems Catalent Pharma Soluitions- RTP Morrisville, NC, United States jacqueline.crawford@catalent.com

Jacques Mowrer Director Analytical Development Threshold Pharmaceuticals South San Francisco, CA, United States jmowrer@thresholdpharm.com

Jagdamba Prasad Manager Sigmapharm laboratories Bensalem, PA, United States jprasad@sigmapharm.com

Jalal Jafri CEO & President DS Technologies Darien, CT, United States jjafri@dstechcorp.com

James Brown Senior regulatory manager Goldbelt Raven LLC Frederick, MD, United States edwardbrown1@gmail.com

james cox Sr Analytical Chemist/ Lab Supervisor Thibiant Chattsworth, CA, United States jcox@thibiant.com

James Duffy Supplier Quality Manager Perrigo Minneapolis, MN, United States jim.duffy@perrigo.com

James Kang Manager Neo Kimchi Bio-Active, Inc. San Jose, CA, United States jhkang24@gmail.com

James Whitehead VP Quality and Regulatory Affairs Reliable Biopharmaceutical Corp Saint Louis, MO, United States jwhitehead@reliablebiopharm.com

Jami Knight Analytical Chemist IGI Labs, Inc. Buena, NJ, United States Jamiknight@igilabs.com

Janak Patel AGM Quality Unit Halcyon Labs Private Limited Ahmedabad, Non-US, India jpatel@encoregroup.net

Jane xiang Manager of Product Development Flavine North America, Inc Closter, NJ, United States jane.qiu.xiang@flavine.com

Janice Vu Quality control EO products San Rafael, CA, United States janice@eoproducts.com

Janie Russell Regulatory Affairs Specialist NIH Bethesda, MD, United States russelljb@niaid.nih.gov

Jannina Suxe Ramirez Químico Farmaceutico Dirección de Medicamentos Insumos y Drogas Lima, Non-US, Peru qfjsuxe@gmail.com

Jason Alba Sr. Manager Domain WIPRO Irvine, CA, United States jason.alba@wipro.com

Jason Edwards Packaging Supervisor IGI Laboratories, Inc. Buena, NJ, United States jasonedwards@igilabs.com

Jason Gillette VP of Regulatory Compliance Westminster Pharmaceuticals, LLC Odessa, FL, United States jgillette@westminsterrx.com

Javorka Gunic QA Manager Evofem Inc San Diego, CA, United States jgunic@evofem.com

Jay Tanna Associate Consultant EY Mumbai, Non-US, India jay1.tanna@in.ey.com

Jaya Dhiman Dhiman Corporate Quality Assurance Sentiss Pharma Pvt Ltd Gurgaon, Non-US, India jaya2543@gmail.com

Jayashree Patel Sr. Regulatory compliance associate Teva pharmaceutical US Pomona, NY, United States jayashree.patel@tevapharm.com

Jean Crawford QA/Medical Affairs Specialist Nostrum Laboratories Inc. Kansas City, MO, United States jcrawford@nostrumlabs.cm

Jean Crawford QA/Medical Affairs Specialist Nostrum Laboratories Inc Kansas City, MO, United States mkngitwrk24@yahoo.com

Jeannine Ramsey Consultant Accurate Clinical Solutions Wellington, OH, United States Jeannine_Ramsey@icloud.com

Jeffrey Fenerty Executive Director of Sterile Compounding Pharmalogic CSP Bridgeport, WV, United States Jfenerty@pharmalogic.info

Jen Pendlebury Dector, Regualtory Affairs Novadaq Technologies Mississauga, Non-US, Canada jpendlebury@novadaq.com

Jena Strauss-Schoenberger Regulatory Affairs Associate ISTO Technologies, Inc. St. Louis, MO, United States jstrauss@istotech.com

Jeness Jose Associate III- Regulatory Affairs sandoz Princeton, NJ, United States jeness.alex@gmail.com

Jenn Snodgrass Director QC Labs PD Pharmatech Seymour, IN, Afghanistan jsnodgrass@particledy.com

Jennie Allewell Sr Director Regulatory Affairs Cambrex Corporation East Rutherford, NJ, United States Jennie.allewell@cambrex.com

jennifer chenault QA kppt bloomington, IN, United States jchenault3@ivytech.edu

Jennifer Bakula Senior Quality Manager Akorn Pharmaceuticals Lake Forest, IL, United States jen.bakula@akorn.com

jennifer chenault QA kp pharmaceutical bloomington, IN, United States jchenault@kppt.com

Jennifer Chmura Quality Assurance Associate Pharmaceutics International, Inc. Hunt Valley, MD, United States jchmura@pharm-int.com

Jennifer Fetterolf Sr. Manager, Quality Assurance Chiesi USA, Inc. Cary, NC, United States jennifer.fetterolf@chiesi.com

Jennifer Morgan Manufacturing Manager Osiris Therapeutics, Inc. Columbia, MD, United States jmorgan@osiris.com

Jennifer Morgan Manufacturing Manager Osiris Therapeutics Columbia, MD, United States jmorgan@osirs.com

Jennifer Sensenig Clinical Research Coordinator The Ohio State University Medical Center Columbus, OH, United States Jennifer.Sensenig@osumc.edu

Jennifer Sievers Quality Director Apothecares Supply Decatur, AL, United States jennifer.sievers@southerncompounding.com

Jenny (Shun Yin) Fong Head of Compliance Hovione LLC East Windsor, NJ, United States jfong@hovione.com

JENNY RAO Regulatory Specialist Shenzhen Hepalink Pharmaceutical Ltd., Co. Shenzhen, Non-US, China dayin2011@yeah.net

Jenny Steele Repack Specialist Apotheca Supply, Inc. Decatur, AL, United States jenny@apothecares.com

Jeremy Richardson Complaint Coordinator Telcare Medical Supply Concord, MA, United States jrichardson@telcaresupport.com

Jerilyn Spencer Quality Assurance Manager Horizon Pharmaceuticals, Inc. Riviera Beach, FL, United States jspencer@horizonph.com

Jerry Brandewie Consultant IBTS Spring, TX, United States jtbrandewie@gmail.com

Jessica Haas Assistant Quality Manager Powdersize, Inc. Quakertown, PA, United States jhaas@powdersize.com

Jessica VanKirk Chemist Next Science, LLC Jacksonville, FL, United States jvankirk@nextscience.org

Jessica VanMeter Sr. RA Specialist Qualitest Huntsville, AL, United States jvanmeter@qualitestrx.com

Jessika Lima de Azevedo Quality Assurance Auditor Prati Donaduzzi Ltda Toledo, Non-US, Brazil jessika.azevedo@pratidonaduzzi.com.br

Jessika Lima de Azevedo Quality Assurance Auditor Prati DOnaduzzi Ltda Toledo, Non-US, Brazil jessikalazevedo@hotmail.com.br

jhonathan israel gonzález acosta asistente de producción laboratorio medrock corperation S.A lima, Non-US, Peru jhony_16_188@hotmail.com

Jia Wang QA Analyst PuraCap Pharmaceutical LLC South Plainfield, NJ, United States jia.wang@puracap.com

Jianhua Tang Manager Dynport vaccine llc Frederick, MD, United States jtang30@csc.com

Jieun Lee Associate Celltrion Pharm Cheongju-si, Non-US, South Korea jieun.lee@celltrionph.com

jigisha varia Senior Manager, Reg Affairs Evenus Pharmaceutical Industries Inc Princeton, NJ, United States variaj@evenuspharma.com

Jillian Collins Sr. QA Specialist Charles River Laboratories Charleston, SC, United States jillian.collins@crl.com

Jingran Lu regulatory speclist prinston pharmacutical East Windsor, NJ, United States jingran.lu@prinstonpharm.com

Jinjie Hu Senior Consultant BCG Alexandria, VA, United States jhu@bcg-usa.com

Jinous Saeedi Sr.Specialist RA/QA Irvine Pharmaceutical Services Irvine, CA, United States jinoussaeedi@gmail.com

Jinseok Jeon General Manager BCWorld Pharm. Co., Ltd. Seoul, Non-US, South Korea jjjindol@gmail.com

Jitendra Parmar Production Manager Bio-Pharm Inc. Levittown, PA, United States jitendraparmar@bio-pharminc.com

Jo Collins Manager, Quality Clinical Compliance Ora, Inc. Andover, MA, United States jcollins@oraclinical.com

Joachim Troost Senior Associate Director Boehringer Ingelheim Ridgefield, CT, United States joachim.troost@boehringer-ingelheim.com

Joan Fanis QA Manager Sterile Forms Rafarm S.A. Athens, Non-US, Greece i.papatheofani@rafarm.gr

Joanne Marriott Sr, VP Quality Amerigen Pharmaceuticals Inc Lyndhurst, NJ, United States jmarriott@amerigenpharma.com

Joaquin Perez Manager Laboratorios Pisa SA de CV Jalisco, Non-US, Mexico jqperez@pisa.com.mx

Joe Murphy Director, Combination Products Compliance Janssen Pharmaceuticals Neuchatel, Non-US, Switzerland jmurph28@its.jnj.com Joel Selcher

Head of Regulatory Strategy Jazz Pharmaceuticals, Inc. Palo Alto, CA, United States joel.selcher@jazzpharma.com

Joey Hu Regulatory Affairs CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China huyaxing@mail.ecspc.com

John F Ekpe Manager, Clincal Chemistry TUH Philadelphia, PA, United States jofrek0812@gmail.com

John Kim VP Quality, Regulatory and Viligance Pierre Fabre Pharmaceuticals, Inc. Parsippany, NJ, United States jkim@pfpharmausa.com

John Lester IT & Facilities Manager ImmunoScience, Inc Pleasanton, CA, United States john.lester@immunoscience.com

John Maddalena Quality Director Haemtech Biopharma Services Essex Junction, VT, United States jmaddalena@haemtech.net

John Metcalfe Senior Microbiology Reviewer FDA Silver Spring, MD, United States john.metcalfe@fda.hhs.gov

John Miller VP US Compliance Fresenius Kabi Lake Zurich, IL, United States John.R.Miller@Fresenius-kabi.com

John Oberholtzer Senior Regulatory Affairs Manager Celerity Pharmaceuticals, LLC Bartlett, IL, United States joberholtzer@celeritypharma.com

john punzi Director QA and Tech Affairs chpa Wash, DC, United States john_punzi@yahoo.com

john punzi Dir QA/ TECH AFFAIRS chpa washigton, DC, United States jpunzi@chpa.org

Jon Beaver Vice President of Quality Control Focus Laboratories, Inc. North Little Rock, AR, United States jon.beaver@focuslaboratories.com

Jonas Kazmirczak Analist of Supplier Qualification Prati Donaduzzi Toledo, Non-US, Brazil jonaskzk@gmail.com

jose brenis jefe de produccion lab. Medrock corp. Lima, Non-US, Peru jbrenis@alumni.unav.es

José Luis Correa Vásquez EVALUATOR DIRECCIÓN GENERAL DE MEDICAMENTOS INSUMOS Y DROGAS DEL PERÚ LIMA, Non-US, Peru jcorrea@digemid.minsa.gob.pe

Joshua McCartney QA Auditor I Charles River Laboratories Charleston, SC, United States joshua.mccartney@crl.com

Joy Frestedt President and CEO Frestedt Incorporated Saint Louis Park, MN, United States jf@frestedt.com

Joy Trepanier QA Manager Hill Dermaceuticals Inc Sanford, FL, United States joy.trepanier@hillderm.com

Joyce Frey-Vasconcells Regulatory Consultnat Frey-Vasconcells Consulting, LLC Sykesville, MD, United States jfrey@freyvasconcells.com

Joyce Nwangwa Sr. Quality Systems Specialist Catalent Pharma Solutions Morrisville, NC, United States joyce.nwangwa@catalent.com

JS REDDY HEAD QUALITY HONOUR LAB LTD VISHAKAPATNAM, Non-US, India srinivas0621@rediffmail.com

Juan He Senior Director, Pharmacometrics BioPharma Services Inc. Toronto, Non-US, Canada jhe@biopharmaservices.com

JUAN BOTANA GMP-COMPLIANCE HEAD INKE BARCELONE, Non-US, Spain jmbotana@inke.es

Juan Gutierrez Manager Laboratorios Pisa SA de CV Jalisco, Non-US, Mexico jgutierrez@pisa.com.mx

Juan Manuel Reategui Torrejon Quimico Farmaceutico Independiente Lima, PA, Peru juanreategui25@gmail.com

Juan Olivares León Head of Quality And Regulatory Affairs Siemens Lima, Non-US, Peru juan.olivares@siemens.com

Juan Zha RA, deputy director Zhejiang Medicine Co., Ltd. Xinchang Pharma Xinchang, Zhejiang, Non-US, China zhaj@xcpharma.com Judith Cohen

Director Quality Particle Sciences Inc Bethlehem, PA, United States jcohen@particlesciences.com

Judith Samardelis Global IT Quality and Compliance Astrazenca Gaithersburg, MD, United States judith.samardelis@astrazeneca.com

Judy McMeekin Staff Director, Medical Products and Tobacco Policy FDA/ORA Silver Spring, MD, United States judith.mcmeekin@fda.hhs.gov Julia Griselda Sarmiento

EVALUADOR DIGEMID LIMA, Non-US, Peru jsarmiento4@yahoo.com

Julia Zhu R&A Manager Flavine Shanghai, Non-US, China zhuyujiao1972@hotmail.com

Juliana Rodriguez PHARMACIST DIGEMID LIMA, Non-US, Peru julypilar@hotmail.com

Julie Gerlach Clinical Division Director Compliance Insight Inc. Fairfield, OH, United States Julie@Compliance-Insight.com

Julienne Pearson Regulatory associate Teva Woodcliff Lake, NJ, United States julienne.pearson@tevapharm.com

JULIO CASTAÑEDA FARMACEUTICO DIGEMID LIMA, Non-US, Peru jccp_lp@hotmail.com

Julivet Nuñez Biotechnologist Medistem Panama Inc Panamá, Non-US, Panama jnunez@medistemresearch.com

Jun Gao Director, Global Alliance Management Sagent Pharmaceuticals, Inc. Schaumburg, IL, United States jgao@sagentpharma.com

Junle Ren Senior R&D engineer Yiling Pharmaceutical Ltd Shijiazhuang, Non-US, China maysoler@qq.com

Justyna Mazur QA/QC Manager OHM Pharma, Inc. Mineral Wells, TX, United States jmazur@ohmpharma.com

Jyothi Matharu VP, Quality KP Pharmaceutical Technology I Bloomington, IN, United States jmatharu@kppt.com

Kaci Rosales Quality Assurance and Regulatory Affairs Specialist Allergy Laboratories, Inc. Oklahoma City, OK, United States krosales@allergylabs.com Kairon Nóbrega Riguete

Project Management Prati Donaduzzi Toledo, Non-US, Brazil kairon.riguete@pratidonaduzzi.com.br

Kaitlyn Riffel Consultant, Scientific Consulting Cardinal Health Overland Park, KS, United States kaitlyn.riffel@cardinalhealth.com

KALYANI TAMMAREDDY QUALITY SYSTEMS MANAGER JOHNS HOPKINS UNIV BALTIMORE, MD, United States ktammar1@jhmi.edu

kamal elsayed G M innovation corporation LTD Cairo, CA, Egypt kamalelsayed26@gmail.com

Kamal Negi Quality Assurance Sentiss Pharma Pvt. Ltd. Gurgaon, Non-US, India knegi@sentisspharma.com

Kamana Singh NA NA Chalfont, PA, United States kamana.singh@gmail.com

Kandi Hall Quality Assurance Manager NAMSA Northwood, OH, United States khall@namsa.com

Karan Khairnar Quality management System Wockhardt Ltd Aurangabad, Non-US, India karan7may@gmail.com

Karen Barmore Compliance Team Leader Colgate-Palmolive Greenwood, SC, United States karen_barmore@colpal.com

Karen Cui Biologist NIH Bethesda, MD, United States yongzhikc@gmail.com

Karen Metcalfe Director, Regulatory Affairs DVC Frederick, MD, United States kmetcalfe@csc.com

Karen Rojas Tamata practicing universidad católica de santa maría Arequipa, Non-US, Peru ffy_karen@hotmail.com

Karen Zimm Associate Director CMC Reg Affairs Johnson & Johnson Titusville, NJ, United States kzimm1@its.jnj.com

Karin Au QA and RA Specialist Scynexis Research Triangle Park, NC, United States krngau@gmail.com

Karl Scott Senior Manager, Compliance Johnson & Johnson Ratitan, NJ, United States kscott25@its.jnj.com

Karm Chand Panday QA Validation Celestica Singapore, Non-US, Singapore panday@celestica.com

karoll Gonzalez QS Compliance Analyst Stryker FT. Lauderdale, FL, United States karoll.gonzalez@stryker.com

Kartick Das Manager, Audit & Assurance GlaxoSmithKline Bangladesh Ltd Dhaka, Non-US, Bangladesh kartick.c.das@gsk.com

kasaiah valaparla RA Associate Novo Nordisk Bangalore, IN, India valaparla.kasi@gmail.com

Kasinath Baratam Sr. Executive-Regulatory Affairs Raks Pharma Pvt. Ltd. Vishakapatnam, Non-US, India kasinath.b@hotmail.com

Kate Fang Regulatory Affairs Specialist Yung Shin Pharm. Ind. Co., Ltd. Taichung, Non-US, Taiwan katefang@yungshingroup.com

Katerina Kazakou QA/QC Director RAFARM Athens, Non-US, Greece k.kazakou@rafarm.gr

Katherine DeHaven QA Specialist Ultra Tab Laboratories Highland, NY, United States utlqaspecialist@ultra-seal.com

Katherine Seifert President Seifert & Associates Ventura, CA, United States kls514@aol.com

Katia Melnik RA Specialist G Production Inc. Baie d'Urfé, Non-US, Canada katia.melnik@galderma.com

Katie Dougherty Principal Adjusta Consulting Maple Glen, PA, United States katie.adjusta@gmail.com

Katie Jackson Manager Avalere Health Washington, DC, United States kjackson@avalere.com

Katie Keathley QA Manager Nostrum Laboratories Kansas City, MO, United States kkeathley@nostrumlabs.com

Katrina Smith QA/QC Specialist JHU Cell Processing and Gene Therapy Facility Baltimore, MD, United States ksmith58@jhmi.edu

Kaushik Patel Regulatory Affairs Associate II Teva Pharmaceuticals Horsham, PA, United States kaushik.patel17@tevapharm.com

Kaustubh Gavaskar VP, Quality and Regulatory Affairs Bio-Pharm Inc Levittown, NJ, United States kaustubhgavaskar@bio-pharminc.com

Kay Mitchen Director of Regulatory Affairs Natural Immunogenics Corp Sarasota, FL, United States Kay@n-icorp.cm

Kazuyuki Atarashi Global Program Manager MBL International Woburn, MA, United States kazuyuki.atarashi@mblintl.com

Keith Michels Operations Manager IGI Labs, Inc. Buena, NJ, United States keithmichels@igilabs.com

Keith Mills Director of Research and Research Analyst Trillium Asset Management Boston, MA, United States kmills@trilliuminvest.com

Kelly Garcia Analyst Pratidonaduzzi Toledo, Non-US, Brazil kelly.garcia@gmail.com

Kelly Key Quality Assurance Manager Endo/Qualitest Pharmaceuticals Huntsville, AL, United States kkey@qualitestrx.com

ken nolan Senior Advisor USFDA Silver Spring, MD, United States kenneth.nolan@fda.hhs.gov

Kenneth Petersen Regulatory Associate II Teva Pharmaceuticals Horsham, PA, United States kenneth.petersen@tevapharm.com

Kenny Rogge Reg Affairs and Quality Process Extension Healthcare Fort Wayne, IN, United States krogge@extensionhealthcare.com

Kerri FitzSimmons Project Logistics CoreRx, Inc. Clearwater, FL, United States kerri.fitzsimmons@corerxpharma.com

Ketty Rocio Balabarca Padilla Pharmacits DIGEMID Lima, Non-US, Peru rociobalabarca@gmail.com

Ketul Khamar Quality System Specialist Purdue Pharma Cranbury, NJ, United States ketul.khamar@pharma.com

Kevin Huang Sr. Manager Kashiv Pharma Bridgewater, NJ, United States kevinh@kashivpharma.com

Khemraj Hirani Director, Regulatory affairs and quality assurance University of Miami miller school of medicine Miami, FL, United States Khirani@med.miami.edu

Khurram Khan Regulatory Affairs Manager Blu Pharmaceuticals Franklin, KY, United States kkhan@blurx.us

Kim HuynhBa Executive Director Pharmalytik Newark, DE, United States b2b2day@yahoo.com

Kimberly Ezdebski Vice President Quality & Reg Compliance Chartwell Pharmaceuticals Congers, NY, United States kimberly.ezdebski@chartwellpharma.com

Kimberly Grevera Regulatory Affairs Manager GeNO LLC Cocoa, FL, United States kimberly.grevera@genollc.com

Kimberly Patterson Associate Director WES Pharma, Inc. Westminster, MD, United States kpatterson@wespharma.com

Kimberly Stidd QA Manager KP Pharmaceutical Bloomington, IN, United States kstidd@kppt.com

kinjal joshi Sr. Manager-QA Sun Pharmaceutical Industries Ltd Gurgaon, Non-US, India kinjal.joshi@sunpharma.com

Kinjal Mehta Associate - Regulatory Affairs Sancilio & Company, Inc, Mumbai, FL, India kmehta@sancilio.com

Kinn Chan Director Regulatory Affairs Torrent Pharma Inc. Kalamazoo, MI, United States kinnchan@torrentpharma.us

KIRAN KOLHE ASSOCIATE VP - RA MICRO LABS LIMITED BANGALORE, Non-US, India kirank@microlabs.in

Kirankumar Kota Quality Auditor Azbil Telstar India Pvt. Ltd., Hyderabad, Non-US, India kirankota@ymail.com

Kishore Addanki Assistant Manager Mylan Laboratories LImited hyderabad, Non-US, India kishore.addanki@mylan.in

Korben Knudson Project Specialist RMC Pharmaceutical Solutions Longmont, CO, United States kknudson@rmcpharma.com

krishna chilakamarthy Associate Director Sciegen Pharmaceuticals Hauppauge, NY, United States krishnac@sciegenpharm.com

Kristen Schroeder OPERATIONS MANAGER Vita Key Packaging, Inc. Riverside, CA, United States Kvitakey@gmail.com

Kristen Snaguski Quality Assurance Associate Pierre Fabre Parsippany, NJ, United States ksnaguski@pfpharmausa.com

Kristine Khurshudyan Quality Specialist Esco-Pharm Ltd. Yerevan, Non-US, Armenia kristina.khurshudyan@gmal.com

Kristine Khurshudyan Quality Specialist Esco Pharm Glendale, CA, United States kristina.khurshudyan@gmail.com

Kwok Wu VP of Quality & RA Yiling Pharmaceutical Ltd Shijiazhuang, Non-US, China kwokhang.Yiling@yahoo.com

Lakshmikanth Maddela Manager - Regulatory Affairs Daewoong Pharmaceutical Co. Ltd. hyderabad, Non-US, India lakshmikanthm@daewoong.co.kr

Lara Noah Director, Regulatory Affairs Nexgen Pharma Irvine, CA, United States laranoah@nexgenpharma.com

Laura Kendrick Regulatory Specialist American Health Packaging Columbus, OH, United States lkendrick@americanhealthpackaging.com

Laura Lamas Quality Assurance Assistant Manager Pharmalabenterprises Miami, FL, United States llamas@pharmalabenterprises.com

LAWRENCE EMERE COMPLIANCE MANAGER PREPHARM EWING, NJ, United States okeyemere@yahoo.com

Leah Choi Project Specialist RMC Pharmaceutical Solutions Longmont, CO, United States lchoi@rmcpharma.com

leah kleyn QA Director geri-care pharm Brooklyn, NY, United States leahk@gericarepharm.com

Leanne Sleer Senior Medical Writer INC Research Washington, DC, United States lsleer@hotmail.com

leo su manager sunnypharmtech New taipei city, Non-US, Taiwan leo.su@sunnypharmtech.com

Leona Saunders Head of RA & QA Curis Lexington, MA, United States lsaunders@curis.com

Leonard Krause President FDA Connect, Inc. Eugene, OR, United States lkrause@fda-connect.com

Levi Li Regulatory Affairs CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China lixuntaoo@hotmail.com

li qiao VP Handa Pharmaceuticals Fremont, CA, United States li.qiao@handapharma.com

Lijie Wang Manager, Regulatory Affairs Actavis Parsippany, NJ, United States lijie.wang@actavis.com

Lily Cueva Narro farmaceutico digemid LIma, Non-US, Peru lycueva@yahoo.com.pe

Lin Ping research scientist Jiangsu Simcere Pharmaceutical Group,China Nanjing, Non-US, China linpingmary@gmail.com

Lin Sun Specialist of RA Yiling Pharmaceutical Ltd Shijiazhuang, Non-US, China linlin.sun@yiling.cn

Linda McGovern Quality Assurance Manager SterRx LLC Plattsburgh, NY, United States lmcgovern@aseptpak.com

Linwood Rayford Attorney SBA Office of Advocacy Washington, DC, United States linwood.rayford@sba.gov

Lisa Murray Director of Operations Provenir Garnet Valley, PA, United States lmurray@provenirpharma.com

Lisa Poon-Chuk RA & PV Associate Citron Pharma, LLC. East Brunswick, NJ, United States lpoonchuk@citronpharma.com

lisa tan associate vp of scieces and regulatory affairs GPhA washington dc, DC, United States ltan@gphaonline.org

Lisa Yin Regulatory Affairs Chengdu Easton Pharmaceutical Co., Ltd. Chengdu, Non-US, China ylh@eastonpharma.cn

Lori de los Reyes Sr. Manager, Global Regulatory Affairs, Device Amgen Thousand Oaks, CA, United States ldelosre@amgen.com

Lou Diorio Prinicpal LDT Health Solutions wayne, NJ, United States LSDiorio@LDTRx.com

Lourdes Montanez Regulatory Affairs Specialist Neolpharma, Inc. Caguas, Non-US, Puerto Rico lourdes.montanez@neolpharma.com

Lucja Orzechowski Quality Assurance Auditor Lohmann Therapy Systems West Caldwell, NJ, United States lucja.orzechowski@gmail.com

Luis Carlos Moschetta Supplier Qualification Team Leader Prati, Donaduzzi & Cia Ltda Toledo, Non-US, Brazil luis.moschetta@pratidonaduzzi.com.br

LUIS VELASQUEZ licenciado en biología LMB H.COLICHON S.A.C lima, Non-US, Peru luisrayvc@hotmail.com

Luke Sadowski Plant Manager Hill Dermaceuticals Sanford, FL, United States luke.sadowski@hillderm.com

Ma Kaihua Deputy Manager Zhejiang Huahai Pharmaceutical Co,. Ltd. Neijiang, Non-US, China ma_kh520@126.com

maha lakshmi Regulatory Affairs RAKS PHARMA PRIVATE LIMITED Vishakhapatnam, Non-US, India maha123lakshmi123@gmail.com

mahesh reddy jonnala research associate gland pharma limited hyderabad, Non-US, India jmrmahesh@gmail.com

mahmoud ghannam R&D Project leader Hikma pharmaceuticals Amman, Non-US, Jordan mghannam@hikma.com

Maira Adzema Director Quality Assurance IPM Silver Spring, MD, United States madzema@ipmglobal.org

maithili golhar complaint investigator PL Developments westbury, NY, United States mgolhar@pldevelopments.com

Majid Hasheminejad President 4-1-1 Consulting Services, LLC York, PA, United States majid@411consultingservices.com

Malini Batheja VP of Analytical R&D and Regulatory CMC Saptalis Pharmaceutical HAUPPAUGE, NY, United States malini.batheja@saptalis.com

Manikanta K DRA Executive Gland Pharma Limited Hyderabad, IN, India 35manikanta@gmail.com

Manish Bhatt Quality Manager Colgate Palmolive Morristown, TN, United States Manish_Bhatt@Colpal.com

Manish Sapkota Quality control officer Alive Pharmaceuticals Biratnagar, Non-US, Nepal nature_manish@yahoo.com

Manjunathan Ranganathan Microbiologist Caplinpoint Laboratories limited Chennai, TN, India manjunath_a_r@yahoo.com

Mankit Ho Senior Vice President Kashiv Pharma, LLC Bridgewater, NJ, United States mankith@kashivpharma.com

Marada Satyanarayana Jr.Officer-Regulatory Affairs Raks Pharma Pvt. Ltd. Visakhapatnam, Non-US, India satyanarayana531@rakspharma.in

Marcela Saad President & Senior Consultant MarcM Consulting Canada Kitchener, Non-US, Canada saadma@marcmconsulting.ca

Marcela Spelz Project Coordinator PiSA Farmaceutica Guadalajara, Non-US, Mexico mspelz@pisa.com.mx

Marcia Howard Senior Director, Regulatory & Scientific Affairs Consumer Healthcare Products Association Washington, DC, United States mhoward@chpa.org Marcy Wylie

Sr. Compliance Auditor Catalent Pharma Solutions Morrisville, NC, United States marcy.wylie@catalent.com

Margaret Choy EVP, Regulatory Affairs & Compliance Pharmadax USA, Inc. Irvine, CA, United States margaret.choy@pharmadax.com

Maria Consuelo Neyra Cabezudo Quimico Farmaceutico DIGEMID- PERU Lima, Non-US, Peru neyramc3@gmail.com

Maria Caturla Clinical Research Monitoring Specialist University of Pennsylvania Philadelphia, PA, United States caturm@exchange.upenn.edu

Maria Ferreira Quality Assurance Director Laboratorios PiSA SA de CV Guadalajara, Non-US, Mexico msuarez@pisa.com.mx

Maria Isabel Quicano Velasquez Assistant Pharmacist QUIMFA PERU SAC Lima, Non-US, Peru mariaisabelquicanovelasquez@gmail.com

Maria McGarry Founder biolicensure montclair, NJ, United States maria.mcgarry@biolicensure.com

Mariam Shokralla project manager Egyptian Drug Authority Rockville, MD, Egypt mshokra@emory.edu

Marianne Scheffler President Scheffler & Associates Carmel, NY, United States cmcc@pipeline.com

Marie Dorat Principal Consultant/CEO IPRF, LLC San Diego, CA, United States mariedorat@yahoo.com

Marietsy Pujol Research Analyst University of Miami Miami, FL, United States mpujol@med.miami.edu

MARIO DEL TORO Manufacturing Operations Director Pisa Farmaceutica S.A de C.V. Guadalajara, Jalisco, Non-US, Mexico mdeltoro@pisa.com.mx

Mariola Mier Executive Consultant Pharma Quality Europe Mexico, Non-US, Mexico m.mier@pqe.eu

Marisol Rodriguez QA and QC Manager Interquim S.A. de C.V. Cuautitlan Izcalli, Non-US, Mexico mrodriguez@interquim.com.mx

Marissa Cordo Regulatory Affairs Associate Teva Pharmaceuticals USA Horsham, PA, United States marissa.cordo@tevapharm.com

Maritza Marquez Document Specialist Roche Tissue Diagnostics Tucson, AZ, United States maritza.marquez@ventana.roche.com

Maritza Sosa Jimenez Quality and Compliance Prime Enterprises, Inc. Miramar, FL, United States Maritzas@primeenterprises.com

Mark Hendrickson Dir Reg Sci GPhA Washington, DC, United States mhendrickson@gphaonline.org

Mark Mitcher VP Quality Assurance ChemAid Laboratories Saddle brook, NJ, United States mmitcher@chemaidlabs.com

Mark Wita VP QA RA Pharmaceutical Associates, LLC Tampa, FL, United States mwita@pa-labs.com

Marla Tegtmeier QA Cordinator HP Enterprise Des Moines, IA, United States marla.tegtmeier@hp.com

Marta Lisiakiewicz Research Associate MedinCell Jacou, Non-US, France marta.lisiakiewicz@medincell.eu

Martine Poisson Validation supervisor Galderma Baie d'Urfé, Non-US, Canada martine.poisson@galderma.com

Marvin Garrett Vice President Aerie Pharmaceuticals Irvine, CA, United States marvinjgarrett@gmail.com

Mary Bame Senior Specialist: Auditing and Document Control Mylan Pharmaceuticals Greensboro, NC, United States mary.bame@mylan.com

Mary Clark General Manager PharmaGenetico San Antonio, TX, United States mlopezclark@pharmagenetico.com

Mary Foster Managing Director Pharma Consulting - The Foster Group Blue Bell, PA, United States mary.sg.foster@gmail.com

Mary Wood Regulatory/Quality BioConvergence Bloomington, IN, United States mary.wood@bioc.us

Marycarmen Nieto Director QA Pisa-Biopharm Albany, NY, United States mcnieto02@gmail.com

Marycarmen Nieto Director of QA/RA Pisa Biopharm Albany, NY, United States mnieto@pisa-biopharm.com

Masayoshi Nishiyama owner Nishiyama Consulting Office Tokyo, Non-US, Japan ezi04121@nifty.com

MATHEW GEORGE General Manager Cadila Healthcare Limited Vadodara, Non-US, India Mathew.George@zyduscadila.com

MATILDE HUARI MARIN evaluador DIGEMID-MINSA Lima, Non-US, Peru mathy.h@gmail.com

Matt Cohen Director of Technical Services SA Analytical MUNDELEIN, IL, United States mcohen@saanalytical.com

Matt Potter QA Pharmacist Roadrunner Pharmacy Phoenix, AZ, United States mpotter@roadrunnerpharmacy.com

Maureen Kozuch Regulatory Manager Dow Chemical Midland, MI, United States mkozuch@dow.com

Maurice Briggs Principal GMB Bio:Pharma Development Harleysville, PA, United States gmbriggs@comcast.net

Maya Kharawala Director of Analytical/Quality Orit Laboratories LLC West Caldwell, NJ, United States maya@oritlabs.com

Mayra Guzman-Kaslow President GK Regulatory Complaince & Enginering Consulting LLC West Palm Beach, FL, United States mguzmankaslow@gkregulatorycompliance.com

Meena Surana Director, QA & RA Polygen Pharmaceutcials LLC Edgewood, NY, United States meena@polygenpharma.com

Meenakshi Muthiah Regulatory Operations Specialist DynPort Vaccine Company LLC Frederick, MD, United States 26.meenakshi.c@gmail.com

Meghan Heffernan Quality Control Supervisor IGI Labs, Inc. Buena, NJ, United States meghanheffernan@igilabs.com

Mehul Gandhi QA Manager NLI Kansas City, MO, United States mgandhi@nostrumlabs.com

Mehwish Saeed Senior Executive Quality Assurance Documentation Scilife Pharma (Pvt.) Limited Karachi, Non-US, Pakistan mehwish.saeed.siddiqui@gmail.com

Meifang Jiang Director of Quality Control Lab Xttrium Laboratories, Inc. Mount Prospect, IL, United States mjiang@xttrium.com

Melissa Basnight Director Regulatory & Quality LifeScience Logistics Dallas, TX, United States mbasnight@lslog.com

Melissa McMichael Quality Assurance Auditor Alliance Pharma Malvern, PA, United States mmcmichael@alliancepharmaco.com

Melody Tsai GMP Processing Supervisor TissueTech, Inc Doral, FL, United States mtsai@tissuetechinc.com

Michael Mackie QC Laboratory Supervisro Xttrium Laboratories Mount Prospect, IL, United States mmackie@xttrium.com

Michael Ayeni QA Compliance Specialist Johnson Matthey Pharmaceutical Material West Deptford, NJ, United States Ayeniml@JMUSA.COM

Michael Barron Director Quality Chemical Laboratories Wilmington, NC, United States michael.barron@qualitychemlabs.com

Michael Beckelic Manager, Quality and Regulatory Affairs Sebela Pharmaceuticals Inc. Roswell, GA, United States mike.beckelic@sebelapharma.com

Michael Boyd Corporate Quality Assurance Auditor Procter & Gamble CIncinnati, OH, United States boyd.mg@pg.com

Michael Channing Radiochemist National Institutes of Health Bethesda, MD, United States mc30x@nih.gov

Michael Fountoulakis Director, Quality Assurance AustarPharma, LLC Edison, NJ, United States michael.fountoulakis@austarpharma.com

Michael Megargee Senior GMP Specialist U.S. Pharmacopeial Convention Rockville, MD, United States mlm@usp.org

Michael Ok Post-Doc University of Wuerzburg Wuerzburg, Non-US, Germany Michael.Ok@t-online.de

Michael Powanda President M/P Biomedical Consultants LLC Mill Valley, CA, United States powanda@mpbiomed.com

Michael Schwöppe Project Manager tesa Labtec GmbH Langenfeld, Non-US, Germany michael.schwoeppe@tesa.com

Michele Desjardins CMO Quality Manager Galderma Baie d'rUfé, Non-US, Canada michele.desjardins@galderma.com

Michelle Espiritu Senior CRC Clinical Trial Network Houston, TX, United States mespiritu@ctntexas.com

Michelle Saylor Product Compliance Scientist USAMMDA Frederick, MD, United States michelle.l.saylor.ctr@mail.mil

Michelle Yorke Sr. QC Manager Biodel Inc. Danbury, CT, United States myorke@biodel.com

Miguel Mercier Deputy Director Sanofi Pasteur Toronto, Non-US, Canada miguel.mercier@sanofipasteur.ca

Mike Dempsey Manager of Quality Assurance PD Pharmatech Seymour, IN, United States mdempsey@pdhllc.com

Mike Kirkbride VP Clinical American HomePatient` Tampa, FL, United States mike.kirkbride@ahom.com

Mike Yelvigi Managing Partner CPI Pharma Basking Ridge,, NJ, United States myelvigi@cpipharma.com

MILAGROS HEREDIA ALFARO CATALOGATION DIGEMID LIMA, Non-US, Peru maritzaheredia123@hotmail.com

milton pena Pharmacist Ministry Of Health Lima, Non-US, Peru miltoncpm@hotmail.com

min chen Senior Manager, Regulatory Affairs Ultragenyx Pharmaceutical Inc. Novato, CA, United States mchen@ultragenyx.com

Min Sik Shin Assistant Manager BCWORLD PHARM Seoul, Non-US, South Korea msshin629@bcwp.co.kr

Minerva Hughes Branch Chief FDA Silver Spring, MD, United States minerva.hughes@fda.hhs.gov

Miriam Montante Residues Toxic Manager Laboratorio Central Regional del Norte Guadalupe, Non-US, Mexico miriam.montante@gmail.com

Mitesh Bhadricha Consultant EY Mumbai, Non-US, India mitesh.bhadricha@in.ey.com

Mithun NM Senior Process Associate TCS Pune, Non-US, India mithunnymthi@gmail.com

Mitsu Fink Quality Control Specialist Memorial Sloan Kettering Cancer Center New York, NY, United States finkm@mskcc.org

mitul patel asst manager sun vadodara, Non-US, India mitul.patel@sunpharma.com

MOGALI RAMBABU Assistant General Manager-Regulatory Affairs Raks pharma Pvt. Ltd Visakhapatnam, Non-US, India rambabumogali@rakspharma.com Mohamad Amiruddin Mohamad Nor

Supplier Quality Engineer Celestica (M) Sdn Bhd Johor Bahru, Non-US, Malaysia mohamadn@celestica.com

mohammad azad technical manager healthcare pharmaceuticals limited dhaka, Non-US, Bangladesh akazad@hpl.com.bd

Mohammed Yousffi Quality Assurance Auditor Fresenius Kabi USA, LLC Melrose Park, IL, United States Mohammed.Yousffi@gmail.com

Mona Malhotra Senior Manager Corporate Quality Assurance Sentiss Pharma Pvt. Ltd Gurgaon, Non-US, India batramonain@yahoo.com

Montserrat Megías Regulatory Documentation Manager INKE, S.A. Castellbisbal, Non-US, Spain mmegias@inke.es

Na Rae Song Business Developer Dong Sung World Wide USA, Inc. Cerritos, CA, United States naraesongds@gmail.com

Nadia Osman Clinical trial Coordinator OSU Columbus, OH, United States nadia.osman@osumc.edu

Naga Mahendar Velishala Vice President Mirror Pharmaceuticals LLC Fairfield, NJ, United States nagamahendar@mirrorpharma.com

Nagaraj Reddy Managing Director Ascenders Consulting Services Bangalore, KS, India nagaraj@a-cs.co.uk

NAGARAJ TOLNOORKAR QUALITY ASSURANCE ALLURE LABS HAYWARD, CA, United States nagarajbt17@gmail.com

NAGARJUNA BHOGADI REGULATORY AFFAIRS DAEWOONG PHARMA HYDERABAD, Non-US, India NAGARJUNAA258@GMAIL.COM

Naheed Sayeed Manager, Process Validation, TO Apotex Toronto, Non-US, Canada nsayeed1@apotex.com

Nancy Feng Regulatory Affairs CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China fengnan1013@163.com

Nancy Lonnroth Director AMAG Derry, NH, United States daxund@comcast.net

Nancy martin Document Control Associate II Nostrum Laboratories Inc. Kansas city, MO, United States nmartin@nostrumlabs.com

Nancy Muzik Associate Director, Quality Assessment Shionogi Inc. Alpharetta, GA, United States nmuzik@shionogi.com

Nandkumar Chodankar CEO ASolution Pharmaceuticals Pvt. Ltd Mumbai, Non-US, India nandkumar@asolution.in

Nanduri Venkata Ramana Kumar General Manager SunPharma Industries Limited Gurgoan, Non-US, India narayana_jai@rediffmail.com

Narendira Kumar Senior Manager Orchid Healthcare Chennai, Non-US, India narendiram@orchidpharma.com

Narendrasinh Gohil Quality Assurance Pharmaceutics International Inc Hunat Valley, MD, United States narendrasinhgohil@hotmail.com

Nasrin Mehranmehr Expert Avicenna Research Institute Tehran, Non-US, Iran n.mehranmehr@gmail.com

Naveen Yadav Sr. Executive Megafine Pharma (P) Limited Nashik, Non-US, India naveen.yadav@megafine.in

Nayaz Ahmed Director Quality & PD PrimaPharm.net San Diego, CA, United States nayaz@primapharm.net

Neel Patel Project Manager Orit Laboratories LLC West Caldwell, NJ, United States neel@oritlabs.com

neha yadav Regulatory affairs Daewoong Pharamceutical hyderabad, Non-US, India neha@daewoong.co.kr

NEHRU GADDIPATI CEO NINES CONSULT PHARMA NEW YORK, NY, United States NEHRU.GADDIPATI@NINESPHARMA.COM

Nestor Chihuan Farmaceutico Direccion de Medicamentos del Ministerio de Salud de Peru Lima, Non-US, Peru nestorpedro651@gmail.com Nicole Fisher

RA Manager DVC Frederick, MD, United States nfisher6@csc.com

Nicole Gallo Consultant Halloran Consulting Group Boston, MA, United States ngallo@hallorancg.com

Nicole Leonhardt Quality Specialist Dow Development Laboratories, LLC Petaluma, CA, United States nleonhardt@dowdevelopmentlabs.com

Nicole Motley Compliance Officer Hill Dermaceuticals sanford, FL, United States nicole.motley@hillderm.com

Ninad Sheth Supervisor Taro Pharmaceutical Brampton, Non-US, Canada ninadsheth18@gmail.com

Ningpu Yu Sr Scientist Neuralstem Inc Germantown, MD, United States ningpu@neuralstem.com

Nipun Davar Senior VP. Pharm Dev. and Mfg Threshold Pharmaceuticals South San Francisco, CA, United States ndavar@thresholdpharm.com

Nirav Sevak Regulatory Affairs Specialist Nostrum Laboratories Inc kansas city, MO, United States nsevak@nostrumlabs.com

Nirvi Patel qa specialist II nostrum labs kansas city, MO, United States nirvidpatel@yahoo.com

Nishant sharma Regulatory and Compliance Specialist 1987 HACEKENSACK, NJ, United States nishant@shieldline.com

Nishant Sharma Regulatory and Compliance Specialist Shield line LLC Hackensack, NJ, United States sharma.nishant1987@yahoo.com

Nola Mayo Regulatory Counsel FDA Silver Spring, MD, United States nola.mayo@fda.hhs.gov

Norma Victoria Salazar Guillen Pharmacist DIGEMID Lima, Non-US, Peru norvictoria@yahoo.com

Nrupa Patel Research Scientist Navinta LLC Ewing, NJ, United States nrupa.patel@navinta.com

Nur Hossain pharmaceuticals Navana Pharmaceuticals limited Dhaka, Non-US, Bangladesh nur_011pharm@yahoo.com

Nurjehan Jivani Corporate QA Compliance Auditor Symbio, LLC Fremont, CA, United States njivani@symbioresearch.com

Obaid Ali Federal Inspector of Drugs Drugs Regulatory Authority of Pakistan Karachi, Non-US, Pakistan oarohama@gmail.com

Olga Alfieri Assoc Director Eisai Woodcliff Lakes, NJ, United States olga_alfierii@eisai.com

Olga Alfieri` Associate Director Eisai Woodcliff Lake, NJ, United States olga_alfieri@eisai.com

Omprakash Koshti Deputy General Manager Corporate Quality SUN Phamaceutical Ltd. Vadodara, Non-US, India omkoshtik@yahoo.com

Onesmo Mpanju Principal Consulting LINQ Pharma Consulting Aldie, VA, United States ompanju@linqpharmaconsulting.com

orange zhang RA ZMC shaoxing, Non-US, China orange_lele@hotmail.com

padmavathi rangisetty Senior Executive in Refairsgulatory Af MSN Laboratories Limited Hyderabad, Non-US, India padmavathirangisetty@gmail.com

Pallavi Patil Associate QA Sancilio Pharmaceutical Pvt Ltd Mumbai, Non-US, India ppatil@sancilio.com

Pallavi Shetty Formulation R and D Cronus research labs Pvt Ltd Bangalore, Non-US, India pallavi.tth@gmail.com

Pankaj Ingole Formulation scientist bright future , china Haikou, AL, China ingolepankaj@hotmail.com

Pankaj Kashyap Regulatory Affair Akorn India Private Limited Gurgaon, Non-US, India pankaj.kashyap@akornindia.com

Pankaj Patel Manager Piramal Enterprises Limited Mumbai, Non-US, India pankajkumar.patel@piramal.com

PARINYA SUTHEERASAK Pharmacist HIV-NAT Bangkok, Non-US, Thailand parinya.s@hivnat.org

PASCAL WONGBI External QA Professional III Perrigo Minneapolis, MN, United States pascal.wongbi@perrigo.com

PASHUPATHINATH SIDDAMSHETTY MANUFACTURING CHEMIST SCIEGEN PHARMA INC HAUPPAUGE, NY, United States pashupathinaths@sciegenpharm.com

Pat Stephens President/Owner Medi-Fare Drug Blacksburg, SC, United States pat@medifaredrug.com

Patrice Powers-Feigel Director Tech Ops Midas Pharmaceutical, Inc. Parsippany, NJ, United States patrice.powers-feigel@midas-pharma.com

Patricia Amanqui Especialist evaluation of pharmaceutical product DIGEMID Lima, Non-US, Peru pamanqui@digemid.minsa.gob.pe

Patricia Battonyai de Oliveira Quality Operations Director Bayer HealthcCare Cleveland, TN, United States patricia.battonyai-de-oliveira@bayer.com

Patricia McDonald QA Administration Capstone Nutrition Spring Hill, TN, United States pmcdonald@capstonenutrition.com

Patricia Mendoza Manager, Regulatory Affairs Houston Methodist Research Institute Houston, TX, United States pamendoza@houstonmethodist.org

Patricia Paz Regulatory Affairs Specialist GE Healthcare del Peru SAC Lima, Non-US, Peru patricia.paz@ge.com

Patricia Saulino Manager Medical Affairs Ascend Therapeutics Herndon, VA, United States psaulino@ascendtherapeutics.com

Patrick Neibergall Vice President (QC/RA/DC) Weeks & Leo Co., Inc. Clive, IA, United States patrick@weeksandleo.com

paul cleary Head of Quality EirGen Pharma Waterford, Non-US, Ireland paul.cleary@eirgen.com

Paula Costa Regulatory Affairs Analisty Prati Donaduzzi Toledo, Non-US, Brazil paula.costa@pratidonaduzzi.com

Paula Costa analist Prati Donaduzzi toledo, Non-US, Brazil paulafarma81@gmail.com

Pavadi Subramaniam Senior Manager Quality OHM Labs Inc New Brunswick, NJ, United States subramaniam.pavadi@sunpharma.com

Pawan Kumar Garg Dy. Manager Biocon Limited Bangalore, Non-US, India pawan.garg@biocon.com

Payal Saraf Consultant EY Mumbai, MS, India payal1.saraf@in.ey.com

Peddanna Gumudavelli VP QA Appco Pharma LLC Somerset, NJ, United States peddanna@appcopharma.com

Peggy Cummings Certified Clinical Research Coordinator Lou Ruvo Center for Brain Health Las Vegas, NV, United States simplicity2007@hotmail.com

Peipei Xu Group Leader WuXi AppTec Shanghai, Non-US, China samxu06@126.com

Peram Narayana Manager - Compliance Sun Pharmaceuticals Industries Limited Baddi, Non-US, India peram.narayana@sunpharma.com

peter perfito production manager Endo Pharmaceutical rye, NY, United States perfito.peter@endo.com

Phanindra Singh Associate Project Manager 4C Pharma Solutions Bangalore, Non-US, India phanindra.singh@4cpharma.com

Philip Ashok Karunakaran President - Technical Caplin Point Laboratories Limited Chennai, Non-US, India philip@caplinpoint.net

phyllis sacks QA External Ops LEO Pharmaceutical Parsippany, NJ, United States phyllis.sacks@leo-pharma.com

Pierre M. Eberst Head of QA Galderma Spirig Egerkingen, Non-US, Switzerland pierre-marie.eberst@galderma.com

Pilar Pascual Regulatory Affairs Manager TIARE CONSULTING Madrid, Non-US, Spain dir.tecnica@tiareconsultin.com

Ping Wang principal scientist JNJ Malvern, PA, United States pwang9@its.jnj.com

Poonam Pande Manager Integrated CMC Solutions LLC Chapel Hill NC, NC, United States P.pande@earthlink.net

Postelle Birch-Smith Consumer Safety Officer FDA Silver Spring, MD, United States postelle.birch-smith@fda.hhs.gov

Prachi Khandelwal Manager EY Mumbai, Non-US, India prachi.khandelwal@in.ey.com

pradeep singh Manager Drug Regulatory Affairs Ipca Laboratories Ltd. Mumbai, Non-US, India pradeep2all@gmail.com

Prajakta Palshikar Manager - Regulatory Affairs Alpha MD Pvt Ltd Mumbai, Non-US, India prajakta.palshikar@alphamd.com

Pranav Sarvaiya Consultant EY Mumbai, Non-US, India pranav.sarvaiya@in.ey.com

PRASANNA K BHAT Sr. Regulatory Specialist iMED Global Bangalore, Non-US, India prabioinfo@gmail.com

Prasanna Palle Regulatory Affairs Associate Amneal Pharmaceuticals Hauppauge, NY, United States ppalle@amneal.com

Prashant Vagadia Executive Sun Pharmaceutical Industries Ltd. Vadodara, Non-US, India prashant.vagadia@sunpharma.com

Prassanjit Dey Executive Sun Pharmaceutical Industries Ltd. Vadodara, Non-US, India prassanjit.dey@sunpharma.com

Preston Grondahl Quality Control Lead Guthy Renker Arden, NC, United States Pgrondahl@guthy-renker.com

priyal goyal consultant Ernst and young mumbai, Non-US, India priyal.goyal@in.ey.com

Puiho Yuen R&D, Product Development Dr. Reddy's Laboratories, Inc Princeton, NJ, United States pyuen@drreddys.com

Puja NAGPAL Post Doctoral Scientist ICGEB delhi, Non-US, India pujanii@gmail.com

punit patel Sr Manager Quality Control PL Developments Westbury, NY, United States ppatel@pldevelopments.com

Purvee Patel student Temple University Philadelphia, PA, United States tuf79556@temple.edu

QunQun Decreny QA auditor Alliance Pharma Malvern, PA, United States qdecreny@alliancepharmaco.com

Rachel Tan Quality system specialist Shenzhen Salubris Pharmaceuticals Co., Ltd. Shenzhen, Non-US, China tanhong@salubris.cn Rachelle Ware

Quality Control HP Des Moines, IA, United States rachelle.ware@hp.com

Radha Ramesh Head of Assurance for Life Sciences, NA TCS Bridgewater, NJ, United States radha_19462@yahoo.com

RADHIKA KONDAPAKA Medical Monitor The Emmes Corporation Rockville, MD, United States rkondapaka@emmes.com

RAFAEL COMAS Regulatory Affairs Coordinator PROCAPS S.A. BARRANQUILLA, CO, Colombia rcomas@procaps.com.co

Raghavendra Rao varada Asst. Manager DR. REDDYS LABORATORIES Visakhapatnam, Non-US, India rao_varada@yahoo.co.in

Raghunandhan Painoori Assistant Manager Novel Laboratories, Inc. Monmouth Junction, NJ, United States praghunandhan@novellabs.net

Raghunath Chigurupati Manager HeteroUsa PISCATAWAY, NJ, United States rchigurupati@heterousa.com

raghuram pannala A.VP QA&RA Sciegen Pharmaceuticals Haupauge, NY, United States raghuramp@sciegenpharm.com

Ragini Mehta Medical technologist-microbiolgy NIH Bethesda, MD, United States rjmehta57@gmail.com

RAJAN DESAI Vice President Quality OLIVE HEALTHCARE MUMBAI, Non-US, India rajan.desai@olivehealthcare.co.in

Rajan Dubey Director Procurement 3tfederal solutions llc BHOPAL, Non-US, India drrajandubey@gmail.com

Rakesh Chaurasia Head of Drug Regulatory Affairs PT DexaMedica Tangerang, Non-US, Indonesia rakesh.chaurasia@dexa-medica.com

Rakesh Lad Vice President AptaPharma Inc Pennsauken, NJ, United States rakesh@aptapharma.com

ramakrishna sampathi Regulatory Affairs Consultant Benta Pharma Industries Beirut, Non-US, Lebanon rama.krishna@bpi.com.lb

Rambabu Mogali Assistant.General Manager-Regulatory Affairs Rakspharma.com visakhapatnam, Non-US, India rambabum@rakspharma.com Rambabu Mogali

Assist.General Manager-Regulatory Affairs Raks Pharma Pvt. Ltd Visakhapatnam, Non-US, India rambabumogali@rediffmail.com

Ramireddy chityala In-process Quality Assurence caplin point laboratories ltd chennai, Non-US, India ramireddy.pharma09@gmail.com

Ramon Genoves Quality manager Celestica Valencia Valencia, Non-US, Spain rgenoves@celestica.com

Ranjana Arote Sr. Manager Regulatory Affairs Enaltec Labs Private Limited Thane, Non-US, India ranjana.arote@enalteclabs.co.in

Raquel Otero Graubard Quality Assurance & Regulatory Director Amino Cell, Inc. Fort Lauderdale, FL, United States raquel@chondropaw.com

Ratna Lingamaneni Director, Regulatory Affairs AbbVie North Chicago, IL, United States ratna.lingamaneni@abbvie.com

Raul Gonzales Global Quality Manager Celestica New York, NY, United States rjgonzal@celestica.com

Ravi Chhatani Manager Actavis Mumbai, Non-US, India ravi.chhatani@actavis.com

Ravi Sankar Kothamasu Manager - Intellectual Property Suven Life Sciences Limited Hyderabad, Non-US, India ravisankar@suven.com

Ravi Srikanth Tallapragada Manager - QA Mirror Pharmaceuticals Fairfield, NJ, United States ravi@mirrorpharma.com

Ravishankar Vadali Associate Director Janssen R&D Springhouse, PA, United States rvadali@its.jnj.com

rebecca cuniff Senior Regulatory Affairs First Priority, Inc. Elgin, IL, United States bcuniff@prioritycare.com

Rebekah Wood Chemist United therapeutics Silver spring, DC, United States Rebekah.r.wood@gmail.com

Reddy kal Director, Quality Systems Fresenius Medical Care Ogden, UT, United States reddy.kal@fmc-na.com

Renae Dixon Assoc Director of Regulatory Affairs CPI Fishers, IN, United States RenaeD@dakins.net

Renate Eggert QA Biotest Dreieich, Non-US, Germany Renate_Eggert@biotest.de

Rene Flores VP Operations DGF Group San Juan, Non-US, Puerto Rico rene.flores@dgfgroup1.com

Renita Johnson-Leva Director ABL Rockville, MD, United States renita1x106@yahoo.com

renu gupta Principal Global Bio-Pharma Consulting Moorestown, NJ, United States renu.gupta@medstech.com

Renuka Yanamadala Asst. Manager Granules india limited Hyderabad, Non-US, India renuka@granulesindia.com

Rhonda Jones President Scientific & Regulatory Consultants, Inc. Columbia City, IN, United States rjones@srcconsultants.com

Richard Reeve Sr. Director R&D Quality Assurance Endo Malvern, PA, United States reeve.richard@endo.com

rikinkumar gandhi Superviosr Quality Yichang Humanwell OSD Plant Yichang, Non-US, China rikinpharma@outlook.com

Rita George Quality Control Manager KP Pharmaceutical Technology Inc. Bloomington, IN, United States rgeorge@kppt.com

Ritesh Panjabi Quality Assurance officer Glenmark Pharmaceuticals Limited Mumabi, Non-US, India ritesh_panjabi@rediffmail.com

Ritesh Panjabi Officer-Quality Assurance Glenmark Pharmaceuticals Ltd Mumbai, Non-US, India ritesh.panjabi@glenmarkpharma.com

Robbie Scott Quality Coordinator Kenco Logistics Chattanooga, TN, United States robbie.scott@kencogroup.com

Robert Bard Managing Director HTC LLC Northville, MI, United States rbard@reglaw.net

Robert Eackles Product Compliance Scientist CRM Frederick, MD, United States robert.g.eackles.ctr@mail.mil

Robert Garcia QA Director Hill Dermaceuticals, Inc. Sanford, FL, United States robert.garcia@hillderm.com

Robert Hauser Executive Vice President Perosphere Inc Danbury, CT, United States r.hauser@perosphere.com

Robert Iser Senior Scientific Advisor (acting) FDA/CDER/OPQ/OPF Silver Spring, MD, United States robert.iser@fda.hhs.gov

Robert Kaster President RK Pharmaceutical Consulting LLC Glenmoore, PA, United States rakaster@comcast.net

Robert Melo President OHM pharma inc Mineral Wells, TX, United States rm@ohmpharma.com

Robert Melo President OHM PHARMA INC Mineral Wells, TX, United States rmelo@ohmpharma.com

Robert Wolfangel VP Scientific Affairs Certus International Inc St. Louis, MO, United States rwolfangel@certusintl.com

Roberto Toledo VP Sales & Marketing DGF Group San Juan, Non-US, Puerto Rico roberto.toledo@dgfgroup1.com

Rock Chen Regulatory Director Easton Pharmaceuticals Chengdu, Non-US, China rock.chen@eastonpharma.cn

Rolando Vega sanitary authorizations - evaluator MINSA - PERÚ Lima, Non-US, Peru qfvega@gmail.com

Rong Pan regulatory affairs specialist Austarpharma LLC Edison, NJ, United States rong.pan@austarpharma.com

Roohi Obaid Deputy Drugs Controller Drug Regulatory Authority of Pakistan KARACHI, Non-US, Pakistan rooahama@gmail.com

Rosa Guzman Consultant DGF Group San Juan, Non-US, Puerto Rico rosa.guzman@dgfgroup1.com

Rosa Lugo Compliance Consultant DGF Group San Juan, Non-US, Puerto Rico rosa.lugo@dgfgroup1.com

Rosa Rivera INSPECTOR MINISTRY OF HEALTH OF PERU LIMA, Non-US, Peru rdriveraro@gmail.com

Rosanna Fajar Senior Research Worker John Hopkins University/Columbia University New York, NY, United States fgreeneyes17@aol.com Rosario Luis

Inspector DIGEMID Lima, Non-US, Peru rluis.ayala@yahoo.es

Rose Zhao Managing Director Emprise Pharma LLC Phoenixville, PA, United States zhaor@EmprisePharma.com

Roshni Patel QA Supervisor Supernus Pharmaceuticals Rockville, MD, United States roshni_bpatel@yahoo.com

Ross Velasquez Quimico Farmaceutico Direccion General de Medicamentos Insumos y Drogas Lima, Non-US, Peru ross_mary79@hotmail.com

Rowen Luna Senior Quality Engineer Fresenius Kabi USA Melrose Park, IL, United States rowen.luna@fresenius-kabi.com

Roxanne Sisak Quality Assurance Manager J Knipper and Company, Inc. Lakewood, NJ, United States roxanne.sisak@knipper.com

Roy R Fennimore Jr Principal Engineer Johnson & Johnson Raritan, NJ, United States rfennimo@its.jnj.com

Ruchi Sahgal Sr. QA, Analytical Astex Pharmaceuticals Pleasanton, CA, United States ruchi.sahgal@astx.com

Ruchi Sahgal Sr. QA, Analytical Astex Pharmaceuticals Pleasanton, CA, United States ruchi_sahgal@yahoo.com

ruhul amin Sr.QA Manager Ad-din pharma Ltd Jessore, Non-US, Bangladesh aminruhul59@yahoo.com

russbelt aliaga Technical director Genzyme Lima, Non-US, Peru russbelt.aliaga@gezyme.com

Russell Fortney Team Leader FDA Silver Spring, MD, United States russell.fortney@fda.hhs.gov

Ruth Aquino QA Manager Specialty Silicone Fabricators, Inc. Tustin, CA, United States Ruth.Aquino@ssfab.com

Ryan McCarthy QA/QC Technician Xttrium Laboratories Mount Prospect, IL, United States rmccarthy@xttrium.com

S BALAJI Deputy Manager QA Caplin point Laboratories Limited Chennai, Non-US, India balaji@caplinpoint.net

Saadia Alam QC Analyst (Validation Coordinator) pfizer pharmaceuticals Karchi, Non-US, Pakistan aftab_sadia@hotmail.com

Sabrina Mon Biotechnologist Medistem Panama Inc. Panama, Non-US, Panama smon@cellmedicine.com

Sachinkumar Patel Chemist US FDA White oak, MD, United States sachinkumar.patel@fda.hhs.gov

Sai Patkar Research Assistant Bionanotechnology Laboratory Philadelphia, PA, United States ssp79@drexel.edu

Sai Patkar Graduate Research Assistant Drexel University Philadelphia, PA, United States saipatkar@gmail.com

Sailaja Chirravuri Regulatory Affairs Officer Mylan Bangalore, Non-US, India sailaja.niper@gmail.com

Sailaja Machiraju Research Associate ParagonBioteck Portland, OR, United States smachiraju@paragobioteck.com

Sally Berry Chief Medical Officer Tris Pharma Monmouth Junction, NJ, United States sberry@trispharma.com

Sam Venugopal Partner PwC San Jose, CA, United States sam.venugopal@gmail.com

Samantha Bouldin Director of Quality Control Advanced Breath Diagnostics Brentwood, TN, United States sbouldin@breathdiagnostics.com

Samantha Kaltenbach Quality Assurance Specialist ISTO Technologies, Inc. St. Louis, MO, United States skaltenbach@istotech.com

Samia Nasr Pharmacologist FDA Silver Spring, MD, United States Samia.nasr@fda.hhs.gov

Sampath Ayyappa Quality Assurance Appcure labs Hyderabad, Non-US, India sampath.g@appcurelabs.com

sandeep uppaluri Sr. QA Compliance Specialist Fresenius Kabi USA schaumburg, IL, United States sandeep.uppaluri@fresenius-kabi.com

Sandra Garrido President TopFire, LLC Plano, TX, United States garridos1@icloud.com

Sanjay Thorat Sr. Executive Genpact-Pharmalink Mumbai, Non-US, India sanjay.thorat@genpact.com

sanjivani kulkarni sr. Manager JBChemicals and pharmaceuticals mumbai, Non-US, India sanjivani.kulkarni@jbcpl.com

sankalp sontakke Internal audit Dr. Reddys laboratories ltd hyderabad, Non-US, India sankalps@drreddys.com

Sanket Patel QA Human Biosciences Gaitherburg, MD, United States sanket@humanbiosciences.com

Sanobar Parkar Director AlphaMD Pvt Ltd Mumbai, Non-US, India drparkar@gmail.com

Santhosh Manupati Drug safety Associate Ascenders Consulting Services Bangalore, KS, India santosh.manupati@a-cs.co.uk

SANTOSH NARLA Manager Regulatory Affairs Laurus Labs private limited Hyderabad, Non-US, India santoshkumar.n@lauruslabs.com

Sara Ethier Senior QA Manager Haemtech Biopharma Services Essex Junction, VT, United States sethier@haemtech.net

Sara Xiao Manager, Regulatory and Supply Chain Hisun Pharmaceuticals USA., Inc Princeton, NJ, United States sara.xiao@hisunusa.com

Sarah Kennedy Document Control Assoicate I Nostrum Labs Kansas City, MO, United States skennedy@nostrumlabs.com

Sarah Serrano Corporate Director Quality Control PL Developments Miami, FL, United States sserrano@pldevelopments.com

SATISH CHAVA Manager Dr.Reddy's Laboratories Ltd Hyderabad, Non-US, India schava@drreddys.com

Savitha Rani Assistant Manager - Regulatory Affairs Orchid Healthcare Chennai, Non-US, India savitha@orchidpharma.com

Scott Murrin Vice President of Quality Capstone Nutrition Ogden, UT, United States smurrin@capstonenutrition.com

season Sun Regulatory Department Yiling Pharmaceutical, Inc. Vegas, NV, United States seasonsunra@yahoo.com

SEEMA GEETHA GOPAL Supervisor Quality Assurance Apotex Inc Richmond Hill, Non-US, Canada seemagbinu@gmail.com

Seema Joshi Manager Sun Pharma Gurgaon, Non-US, India seema.joshi007@yahoo.in

Sena Dissmeyer Sr. QA Associate Pharmaceutics International, Inc. Hunt Valley, MD, United States sdissmeyer@pharm-int.com

Seok Seo Sr. QA Manager Paramount Cosmetics Clifton, NJ, United States youngs@paramountcosmetics.net

Seoung Yong Lee Counselor Embassy of Republic of Korea Washington DC, DC, United States codexlee@gmail.com

sereta muse CONSULTANT QMASC(SC), INC. IRMO, SC, United States sereta.muse@grifols.com

Seth Kreger Product Development Manager Cook MyoSite Pittsburgh, PA, United States seth.kreger@cookmedical.com

Shahper Rahman Regulatory Manager Reckitt Benckiser Parsippany, NJ, United States shahper.rahman@rb.com

Shalender Pratap Singh Quality management system Alkem laboratories Limited Badii, Non-US, India shalender1988@rediffmail.com

Shane Bailey Regulatory Affairs Virtus Pharmaceuticals Tampa, FL, United States sbailey@virtusrx.com

Shanmuka Harish Chalamuri QA Specialist II Nostrum Laboratories Kansas City, MO, United States shanmuka.chalamuri@gmail.com

Sharad Kholambe Executive Sun Pharmaceutical Industries Limited Mumbai, Non-US, India sharad.kholambe@sunpharma.com

Shariq Mehmood Regularly Affairs Executive Pharmevo private limited Karachi, Non-US, Pakistan shariqmehmood7@gmail.com

Sharon Maliar Executive consultant PQE Tel Aviv, Non-US, Israel s.maliar@pqe.eu

sharon Roberts Pharmacist ECI Pharmaceuticals Fort Lauderdale, FL, United States sroberts2@bellsouth.net

Shelley Mendenhall Senior Director, Regulatory and QA Inotek Pharmaceuticals Corporation Lexington, MA, United States smendenhall@inotekpharma.com

shelly fehr IND/IDE Director UPenn philadelphia, PA, United States sfehr@exchange.upenn.edu

Shelly Shirkey Supervisor, Regulatory Affairs Boehringer Ingelheim Chemicals,Inc. Richmond, VA, United States shelly.shirkey@gmail.com

sheree mcgill Manager- QA, ESH, Regulatory PHT International, Inc. Charlotte, NC, United States smcgill@phtchemical.com

sherry elchin director of operations osiris therapeutics, inc collumbia, MD, United States selchin@osiris.com

Shi Qijun project manager chnmed Beijing, Non-US, China pickuparmy@126.com

Shirish Shah CSO, Development and Regulatory EZRA Pharma LLC Phoenix, AZ, United States sshah@ezrapharma.com

shirley shi Executive VP eVenuspharma Princeton, NJ, United States shis@evenuspharma.com

Shuli Cui Regulatory Intern Cerulean Pharma Boston, MA, United States cui.s@husky.neu.edu

shweta singh Executive iMEDGlobal solution Pvt.Ltd Bangalore, KS, India shweta.singh@imedglobal.com

Siba Bhattacharyya Chemist CDER/FDA Silver Spring, MD, United States siba.bhattacharyya@fda.hhs.gov

Sidharth Puri Manufacturing Johnson & Johnson Baddi, Non-US, India spuri3@its.jnj.com

Silsymar Inácio Quality Auditor Prati-Donaduzzi Toledo, Non-US, Brazil silsy.s@gmail.com

Silvane Guzzi project manager Prati Donaduzzi &Cia Ltda Toledo, Non-US, Brazil silvane.guzzi@pratidonaduzzi.com.br

sneha inamdar Associate Apotex miami, FL, United States sinamdar@gmail.com

SNIGDHA BEZAWADA Regulatory Operations Manager CCS Associates San Jose, CA, United States sbezawada@ccsainc.com

Socorro Mogul Sr Director PAR PHARMACEUTICAL INC Chestnut Ridge, NY, United States sokie.mogul@parpharm.com

Sohyun Suk Regulatory Affairs Associate Celltrion Pharm Ochang, Non-US, South Korea sohyun.suk@celltrionph.com

Sonia Haley Regulatory Consultant Halloran consulting group Richmond, VA, United States shvbsetter@comcast.net

Sophia Finckbone Manufacturing Supervisor ISTO Technologies, Inc. Saint Louis, MO, United States sfinckbone@istotech.com

Sophy Abraham Head of Regulatory Affairs Elite Laboratories Inc. Northvale, NJ, United States sabraham@elitepharma.com

SOUSSAN SHAZAND QUALITY ASSURANCE MANAGER PHARMASCIENCE MONTREAL, Non-US, Canada sshazand@pharmascience.com

Sri Polina Regulatory Affairs Specialist PuraCap Pharmaceutical LLC South Plainfield, NJ, United States sravanthi.polina@puracap.com

sri krishna chaitanya jammalamadaka Senior Executive Caplin Point Laboratories Ltd Chennai, Non-US, India chaitanyakrishna.in@gmail.com

Srinivas Peruri Marketing Manager Mylan Laboratories Limited Hyderabad, Non-US, India srinivas_peruri@yahoo.com

srinivas Yandrapu Manager DQA Dr.Reddys Labs Princeton, NJ, United States syandrapu@drreddys.com

Sriramam Rayasam BS Duke Pharmacy Durham, NC, United States rayasam4@gmail.com

SRIRAMAM RAYASAM BS DUKE PHARMACY COMPOUNDING FACILITY DURHAM, NC, United States raysa001@mc.duke.edu

srivalli bontha assistant manager xellia pharmaceuticals bangalore, Non-US, India sreevalli999@gmail.com

Stefan Geanta QA Manager Impopharma Inc. Concord, Non-US, Canada stefang@impopharma.com

Stephan Chang Director Daewoong America Inc. Rockville, MD, United States stephan.chang@deawoong.co.kr

Stephan Chang PhD Daewoong America Inc. Rockville, MD, United States stephan.chang@daewoong.co.kr

stephane charland Suplier Certification mgr Pharmascience Montreal, Non-US, Canada scharlan@pharmascience.com

Stephanie Petaway-HIckson Regulatory / Compliance Manager Calibration Technologies Morris Plains, NJ, United States spetaway36@gmail.com

Stephen Tucker Manager of Product Development Cutanea Life Sciences Wayne, PA, United States stucker@cutanealife.com

Steve Miller Dir. Quality and Regulatory Affiars Air Liquide Healthcare America Houston, TX, United States stevenr.miller@airliquide.com

steve griffith VP - Business Development formpipe Red Bank, NJ, United States steve.griffith@formpipe.com

Steve Hong CEO BCWORLD PHARM Seoul, Non-US, South Korea msshin629@gmail.com

Steve Huang RAS NIH Rockville, MD, United States Huang_steve@rocketmail.com

Steven Goldner Director Quality Assurance Klus Pharma Monmouth Junction, NJ, United States steven.goldner@kluspharma.com

Steven Thomas Senior counsel GSK Raleigh, NC, United States steven.d.thomas@gsk.com

Subramanian Iyer Vice President Mylan Laboratories Limited Hyderabad, Non-US, India subramanian.iyer@mylan.in

Sudhakar Bandari President Aurex Laboratories East Windsor, NJ, United States Sudhakar.bandari@aurexlabs.com

Sue Gifaldi Senior Manager, Compliance Janssen Pharmaceuticals Holley, NY, United States sgifald@its.jnj.com

Sue Wang Manager, Technical Consultant ITRI ROCKVILLE, MD, United States wangs0926@gmail.com

Suhas katare Regulatory Affairs RRPL Mumbai, Non-US, India suhaskatare@gmail.com

Sumeet Parwe RA Sunstar Americas, Inc. Elgin, IL, United States sumeet.parwe@us.sunstar.com

sungil ko RA manager seegene seoul, Non-US, South Korea sikoh@seegene.com

Sunil Dahiya Regulatory Scientist Kinapse Life Sciences Gurgaon, Non-US, India sunil.dahiya@kinapse.com

SUNIL KUMAR Asst Manager Sentiss Pharma private ltd GURGAON, Non-US, India sunilkumar@sentisspharma.com

Suresh Anaganti cGMP auditor Amneal Pharmaceuticals New york, NY, United States suresha@amneal.com

Suresh Kumar Chennaparapu Sr.Manager-Regulatory affairs Raks pharma Pvt. Ltd visakhapatnam, Non-US, India sureshc@rakspharma.com

suresh kumar periyasamy Microbiologist caplin point laboratories ltd chennai, TN, India sureshmb.kumar86@gmail.com

suresh vujjini Sr Manager kashiv pharma Bridgewater, NJ, United States sureshv@kashivpharma.com

surya patra Research Analyst Phillip Capital India pvt Ltd Mumbai, Non-US, India spatra@phillipcapital.com

susan zavala EVALUATOR (DRUG REGISTRATION TEAM) DIGEMID LIMA, Non-US, Peru susan.zavala.coloma@gmail.com

susan fasso CEO Global Pharma GxP consulting cherry Hill, NJ, United States susanfasso@comcast.net

Susan Horth QA Manager Endo Pharmaceutical Rye, NY, United States horth.susan@endo.com

Susan Ocon Quality Control Genentech-Roche Vacaville, CA, United States sdocon@ucdavis.edu

Susan Todd Senior Manager, Regulatory Affairs West-Ward Pharmaceutical Corp Eatontown, NJ, United States stodd@west-ward.com

Suzana Marusic President Hooke Laboratories, Inc. Lawrence, MA, United States s.marusic@hookelabs.com

Swathi Etikala RA Executive Sarvotham Care Secunderabad, Non-US, India etikalaswathi@gmail.com

syed saleem Chief Compliance Officer Apothecary health grand prairie, TX, United States syedsalem@gmail.com

Tab Dobbins QC Senior Supervisor Guthy-Renker Arden, NC, United States tdobbins@guthy-renker.com

Tae-Hyun Park RA staff Celltrion Pharm Cheong-Ju, Non-US, South Korea thp1022@gmail.com

Talpaneni Joseph Sunder Raj Group Analytical Manager Dexa Medica Jakarta, Non-US, Indonesia joseph.talpaneni@dexa-medica.com

Tamara Clark Branch Chief FDA Silver Spring, MD, United States tamara.feltonclark@fda.hhs.gov

Tamra Sami Editor-in-Chief, Quality & Enforcement FDAnews Falls Church, VA, United States tsami@fdanews.com

Tania Galcik RA Specialist DynPort Vaccine Company Frederick, MD, United States tgalcik@yahoo.com

Tania Galcik RA Specialist DynPort Vaccine Company Frederick, MD, United States tgalcik@csc.com

Tania Martinez Regulatory Director Demos Global Group, Inc Miami, FL, United States tm@demosglobal.es

TANIA OVIEDO Inspector - Specialist Dirección General de Medicamentos, Insumos y Drogas Lima, Non-US, Peru qfoviedo@gmail.com

Tara Nath Quality Assurence Caplin point labs ltd., Chennai, TN, India ktn.pharma@gmail.com

Tara Norouzi QA NIH Bethesda, MD, United States norouzit@cc.nih.gov

tatiana short auditor prati-donaduzzi toledo, Non-US, Brazil short.tatiana@gmail.com

Teresa Bales Compliance Specialist Focus CVS Knoxville, TN, United States tbales@focusenv.com

Teresa Hernandez Supervisor Bayer Orizaba, Non-US, Mexico teresa.hernandez@bayer.com

Teresa Tung President Alpha Pharma Services LLC Lake Success, NY, United States teresat@alphapharmaservices.com

Terrie Foster Quality Assurance Document Control Hewlett Packard Des Moines, IA, United States terrie.foster@hp.com

Tetyana Denyssevych quality management officer BC Cancer Agency vancouver, Non-US, Canada tdenysse@bccrc.ca

Tetyana Dusaniwskyj Regulatory Affairs Project Manager Osiris Therapeutics Inc. Columbia, MD, United States tanya.dusan@gmail.com

Thanhhoa Nguyen Scientist Amgen Thousand Oaks, CA, United States thanhhoa@amgen.com

Thomas Berkheimer Quality Assurance Manager Barton Solvents, Inc. Des Moines, IA, United States tomb@barsol.com

Thomas Busmann Manager, Process Engineering Focus Compliance and Validation Services Knoxville, TN, United States tbusmann@focuscvs.com

Thomas Ingallinera VP Pii Hunt Valley, MD, United States tingallinera@pharm-int.com

Threshold Andersen Senior Process Chemist Threshold Pharmaceuticals South San Francisco, CA, United States dandersen@thresholdpharm.com

thrilok p Jr. Executive Caplin Point Laboratories Limited Chennai, Non-US, India p.thrilok@gmail.com

Thuy Nguyen Consumer Safety Officer FDA Silver Spring, MD, United States twee001@yahoo.com

Ti Wang Regulatroy Affairs Manager Jiangsu Hansoh Lianyungang, Non-US, China wt@hansoh.cn

Tim Ames VP, Global Strategic Regulatory Affairs Mylan, Inc. Washington, DC, United States Tim.Ames@mylan.com

Tina G Qiu Ophthalmic Executive Consultant/Principal Directional Healthcare Advisors LLC Peabody, MA, United States tina70qiu@gmail.com

Tina Sanford QA Specialist ImmunoScience, Inc. Dublin, CA, United States Tina.sanford@immunoscience.com

Tina Tong Health Specialist NIH Rockville, MD, United States tina.tong@nih.gov

TJ Higley VP Powdersize Inc Quakertown, PA, United States thigley@powdersize.com

TJ Jacobs Director, IT Global Regulatory Compliance Celestica Inc. Toronto, Non-US, Canada tjjacobs@celestica.com

Todd Lumbert Site Head of Quality SPI Pharma Grand Haven, MI, United States tlumbert@spipharma.com

Todd Sunstrom Director QA ARx Glen Rock, PA, United States tsunstrom@arglobal.com

Tom Bolton Associate Director Regulatory Affairs CMC Nektar Therapeutics Huntsville, AL, United States tbolton@nektar.com

Tom Huang Manager Klus Pharma Inc Monmouth Junction, NJ, United States tom.huang@kluspharma.com

Tomaso Dameno Pharma GMDP Compliance Director PQE Suisse Locarno, Non-US, Switzerland t.dameno@pqe.eu

Tonika Waugh Quality Assurance Associate ImmunoScience Pleasanton, CA, United States tonika.waugh@immunoscience.com

Tooba Murshedkar Associate Director, Regulatory Affairs Sanaria Inc. Rockville, MD, United States tmurshedkar@sanaria.com

Towana Elmore Quality Assurance Manager Convenience Valet Melrose Park, IL, United States telmore@cvalet.com

Travis Bemiss Nuclear Pharmasist Precision Nuclear Gey, TN, United States tbemiss@gmail.com

TRVV Subramanyam Assistant Manager Rakspharma Pvt. Ltd. Visakhapatnam, Non-US, India subramanyam518@rakspharama.in

TRVV Subramanyam Assistant Manager-Regulatory Affairs Raks Pharma Pvt. Ltd. Visakhapatnam, Non-US, India subramanyam518@rakspharma.in

Uday Kompella CSO Ocugen, Inc. Aurora, CO, United States Uday.Kompella@ocugen.com

Udayaraj Kadri Head - Quality Assurance Caplin Point Laboratories Ltd. Chennai, Non-US, India uday@caplinpoint.net

uri shpolansky CTO physiological models pardes hanna carcur, Non-US, Israel uri@physiomodels.com

Utkarsh Jaiswal Assistant Manager Quality Assurance Dr Reddy's Lab Hyderabad, Non-US, India utkarsh_jaiswal999@yahoo.co.in

Valeri Sewald Client Relations Coda Corp USA Westfield, NJ, United States vsewald@codacorpusa.com

Valerie Ahmuty Sr. Director, Regulatory Affairs TherapeuticsMD Boca Raton, FL, United States valerie.ahmuty@therapeuticsMD.com

Vamshidhar Pillarishetty RA Project Manager Amneal Pharmaceuticals Piscataway, NJ, United States vamshidharp@amneal.com

Veeraswamy Cherukuri Manager-QA Lupin Ltd., Mumbai, Non-US, India veerascherukuri@lupin.com

VEERENDRA NANJWADE RESERACH EXECUTIVE UNICHEM LABS Panjim, GA, India vknanjwade@gmail.com

Venkat Ramana Krishna Chunduru Dy.Manager-QA Raks Pharma Visakapatnam, AL, India venkatach@rakspharma.com

VENKAT REDDY SUNKARA Manager - Regulatory Affairs Aesica Pharmaceuticals Ltd Cramlington, Non-US, United Kingdom venkat.sunkara@aesica-pharma.com

venkata varanasi Regulatory Associate riconpharma LLC Denville, NJ, United States venkata.varanasi@hotmail.com

venkatesh alla Sr. Associate Mylan Laboratories Limited Bangalore, Non-US, India venkatesh.a@mylan.com

Venkatreddy Kumbam Senior scientist ScieGen pharmaceuticals Inc Hauppauge, NY, United States vkumbam@gmail.com

Veronique St-Hilaire Quality Projects Specialist Galderma Baie D'Urfé, Non-US, Canada veronique.st-hilaire@galderma.com

VIBHAKAR SHAH Consumer Safety Officer USFDA Silver Spring, MD, United States VIBHAKAR.SHAH@FDA.HHS.GOV

Victor Paulus Head, Regulatory Affairs Advanced Accelerator Applications USA New York, NY, United States victor.paulus@adacap.com

Victoria Scott Associate Director Quality and Regulatory Hemispherx Biopharma, Inc. New Brunswick, NJ, United States victoria.scott@hemispherx.net

vijay kanani Regulatory Affairs - Executive Zydus cadila Vadodara, Non-US, India vijay.kanani@zyduscadila.com

Vijayakumar Balasubramanian Senior Manager Harman Finochem Limited Aurangabad, Non-US, India vijay@harmanfinochem.com

Vijayanand Chakrapani General Manager WOCKHARDT LIMITED Aurangabad, Non-US, India vj.1505@gmail.com

Vilas Malge Assistant Grade I Regulatory Affairs Sun Pharmaceutical Industries Limited Vadodara, Non-US, India vilas.niper@gmail.com

Vilma Naupari Evaluator DIGEMID Lima, Non-US, Peru vnaupari@gmail.com

Vinay Bhatt VP, Quality and R.A. Leading Pharma,LLC Fairfield, NJ, United States vbhatt@leadingpharma.com

Vinayak Pawar Senior Review Microbiologist Food & Drug Administration Silver Spring, MD, United States vinayak.pawar@fda.hhs.gov

Vincent Li Chemist FDA Silver Spring, VA, United States vincent.li@fda.hhs.gov

Vini Patel RA Associate Bio-Pharm Inc. Levittown, PA, United States ra@bio-pharminc.com

Vinicius Beal Boufleur Analyst Prati Donaduzzi Toledo, Non-US, Brazil supplier.qualification@pratidonaduzzi.com.br

Vinod Mandowara Manager-Business Development Sentiss pharma Gurgaon, Non-US, India vmandowara@sentisspharma.com

Vipin Vasanthakumar Manager - Regulatory Affairs Orchid Healthcare Chennai, Non-US, India vipin@orchidpharma.com

virendra khanapure Project Managment APC Pharmaceuticals and Chemicals Mumbai, Non-US, India viren.khanapure@apcgroup.com

Vishal Oza Regulatory Affairs Sun Pharmaceutical Industries Limited Vadodara, Non-US, India voza1686@gmail.com

vishal patel Sr. Regulatory Affairs Teva Pharmaceuticals Horsham, PA, United States vishpharma1980@yahoo.com

Vishal Singh Assisstant General Manager Inventia Healthcare Private Limited Mumbai, MA, India vishal.singh@inventiahealthcare.com

Viswesh Achanta Executive Daewoong Pharmaceutical Co Ltd Hyderabad, Non-US, India aviswesh@daewoong.co.kr

Vivian An RA CSPC Pharmaceutical (Shijiazhuang)Co.,Ltd Shijiazhuang, Non-US, China anzhihong1985@163.com

Wai Yu Regulatory Affairs Supervisor Carlsbad Technology, Inc. Carlsbad, CA, United States karenyu@carlsbadtechnologyinc.com

Walter Jump President Cornerstone Regulatory LLC Langhorne, PA, United States walterjump@cornerstoneregulatory.com

Wanda Hernandez Project Manager TherapeuticsMD Boca Raton, FL, United States wanda.hernandez@therapeuticsmd.com

Warren Crumplin Regulatory Affairs Chemist Fine Chemicals Corporation Cape Town, Non-US, South Africa WCrumplin@aspenpharma.com

Wei Zhang Vice President, QA/QC Youngtech Pharmaceuticals, Inc. Cranbury, NJ, United States wei.zhang@youngtechpharma.com

Weifeng Ji Associate Director Relypsa, Inc Redwood city, CA, United States wji@relypsa.com

weiwei hua PM HPC Bethsda, MD, United States Weiweihua@humphriespcc.com

weiwei hua PM HPC Edison, NJ, United States whua3@jhu.edu

Wendy Galbraith Pharmacist University of Oklahoma Oklahoma City, OK, United States wendy-galbraith@ouhsc.edu

Wendy Linthicum Product Compliance Scientist USAMMDA Frederick, MD, United States wendy.a.linthicum.ctr@mail.mil

Wendy Sanhai Senior managing Scientist Exponent Inc Alexandria, VA, United States Wendysanhai@gmail.com

wendy tan Microbiologist FDA Rockville, MD, United States wendy.tan@fda.hhs.gov

wendy whitfield Regulatory / Compliance Officer Piramal Healthcare UK Limited Morpeth, Non-US, United Kingdom wendy.whitfield@piramal.com

Whitney Dollins Quality Specialist Apothecares Decatur, AL, United States whitney@southerncompounding.com

Whitney Dollins Quality Assurance Specialist Apothecares/ Southern Compounding Decatur, AL, United States whitney@southercompounding.com

wilfredo Pimentel Del Valle pharmaceutical chemist E.B. Pareja Lecaros S.A Lima, ME, Peru wilfredo_pimentel_2507@hotmail.com

Willaine Costa Researcher Prati,Donaduzzi e Cia Ltda Toledo, Non-US, Brazil willaine.costa@pratidonaduzzi.com.br

William Kwok Associate Director, RA BD Rx. Inc Franklin Lakes, NJ, United States william_kwok@bd.com

William Tubbs Director Regulatory Affairs and Quality Assurance Promedior Lexington, MA, United States wtubbs@promedior.com

William Turok President and General Counsel Corporate Pharma, Ltd. Jersey City, NJ, United States Billturok@msn.com

William Turok President and General Counsel Corporate Pharma Jersey City, NJ, United States Corporatepharma@outlook.com

William Washington Director QA Rhodes Pharmaceuticals Coventry, RI, United States william.washington@pharma.com

Willian Tapia Tapia Ramírez Consultor de Catalogación DIGEMID (Dirección General de medicamentos Insumos y Drogas) - Perú Lima, Non-US, Peru wtapia@digemid.minsa.gob.pe wu can

regulatory affairs CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. shijiazhuang, Non-US, China wucan@mail.ecspc.com

Xia Yang assistant Jiangsu Hansoh Pharmaceutical Co., Ltd. princeton, NJ, China sherryyang@hansoh.cn

xian wu Regulatory affairs specialist Jiangsu Hansoh Lianyungang, Non-US, China wx1988919@163.com

Xiaohong Zhang regulatory affair eastonpharma chengdu, Non-US, China zxh@eastonpharma.cn

xiaoli ma QA Furen Hetero Onco therapeutics Ltd. Zhengzhou, Non-US, China cmx5112@126.com

Xiong Lu Registration manager chnmed Beijing, Non-US, China tianshi0600@sina.com.cn

Xiumei Ruan Chemist FDA Silver Spring, MD, United States xiumei.ruan@fda.hhs.gov

xuan zhang regulatory specialist Daewoong Beijing, Non-US, China xuanwe@163.com

Y Wang Director Purdue Stamford, CT, United States yi_2002@yahoo.com

yahya el-kattan VP CMC BioCryst Pharmaceuticals Birmingham, AL, United States yelkattan@biocryst.com

Yanhong Qi QC Manager CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China qyh5@sohu.com

Yanira Gonzalez-Berrios Chemist FDA Silver Spring, MD, United States yanira.gonzalez.berrios@fda.hhs.gov

Yanira Gonzalez-Berrios Chemist FDA Silver Spring, MD, United States yanira.gonzalez-berrios@fda.hhs.gov

Yaolin Wang Regulatory Specialist Hengrui Pharm Shanghai, Non-US, China wangyaolin@yahoo.com

Yarery Smith Microbiologist FDA Silver Spring, MD, United States yarery.smith@fda.hhs.gov

Yaseen Momin Manager Regulatory Affairs Genpharma El Jadida, Non-US, Morocco mominyaseen@gmail.com

Yasuyuki Shimoura QA specifalist Sysmex America Inc. Lincolnshire, IL, United States shimouray@sysmex.com

Ye Zhang Reviewer FDA Silver Spring, MD, United States Ye.Zhang@fda.hhs.gov

Yen Nguyen Sr RA Associate Sandoz princeton, NJ, United States yen-2.nguyen@sandoz.com

Yesmil Pena Consultant Consultant Woodbridge, Non-US, Canada Yesmilpn@gmail.com

Yinka Green Consultant Independent Waltham, MA, United States oluyinka.green@gmail.com

Yolma Gonzalez Staff Scientist SHL pharma Deerfield Beach., FL, United States yolma.gonzalez@shl-group.com

Yonghong Yang Manager Kashiv Pharma LLC Bridgewater, NJ, United States yonghongy@kashivpharma.com

Yongli Lin Regulator affairs manager Zhejinag Starry Pharmaceutical Co., Ltd. Xianju, Non-US, China xjdmf@163.com

York Tomita Science Adv FDA Silver Spring, MD, United States york.tomita@fda.hhs.gov

YSABEL SONIA GUTIERREZ AURES PHARMACYST DIGEMID LIMA, Non-US, Peru sonia9_11@hotmail.com

YU XUE International certification LUYE PHARMA YANTAI, Non-US, China yuxueqa@luye.cn

Zahid Muhammad Director Quality Assurance Pii Towson, PA, United States muhamz@gmail.com

Zhengpin Guan Quality Director Sichuan Qingmu Pharmaceutical Co., Ltd. Chengdu, Non-US, China gsi2008@126.com

zhi chen Manager of regulatory affairs Prinston Pharmaceutical Inc. cranbury, NJ, United States zhi.chen@prinstonpharm.com

Zichun Liu International registration Waterstone(Hubei) Pharmaceutical Co.Ltd Wu han, Non-US, China liuzc040615@126.com

Zulfiqar Choudary QA/RA Manager JABIL Circuits Inc Auburn Hill, MI, United States it_12002@yahoo.com

Zuo Sophia QA manager Zjpharma.Inc. Shijiazhuang, Non-US, China 502570113@qq.com

青郎 RA CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd Shijiazhuang, Non-US, China Langq_2005@163.com

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