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February 5 – 7, 2018 | alexandria, Virginiathe westin alexandria hotel

14th AnnuAlFDA AnD the

ChAnging PArADigm For hCt/P regulAtion

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Please join us as we return to the Westin Alexandria in Alexandria, Virginia, for the 14th Annual FDA and the Changing Paradigm for HCT/P Regulation conference. We are pleased we will have strong representation from FDA and many industry experts crossing the broad spectrum of tissues, cells, and cellular and tissue based products.

Two of the three conference days begin with a moving Recipient Story to remind all of us how important our work is to those recipients that receive these tissue and cell based products. This year we will feature an Emergency Preparedness Panel, where industry representatives will discuss their recent experiences with natural disasters and how these establishments planned and prepared for emergencies. Additionally, there will be updates from the FDA regarding Adverse Reaction Reporting, Donor Eligibility, and Compliance, as well as presentations reviewing Computer Systems & Software Validation and Quality Program requirements related to Training and Personnel.

This year we are featuring more topics of interest to the reproductive tissue industry. In particular, we have included a workshop on Donor Eligibility and Exemption Requests – Reproductive Tissues, where scenarios unique to reproductive tissues will be presented.

The conference format again includes smaller workshops each afternoon that will allow participants to apply the information learned in the morning sessions and allow for interaction between participants, industry experts, and FDA. You can expect to learn as well as provide others with your own experiences and expertise during these sessions.

On the last day of the three-day conference, we will conclude with the ever popular “Ask the FDA” session. Be sure to meet and visit with FDA representatives.

Register early to ensure your participation in a great learning opportunity and the chance to network with experts in your field both from industry and the FDA.

About the Conference

• CEOs&COOs• MDsandMedicalDirectors• DonorScreeners• RegulatoryManagersandPersonnel• RecoveryPersonnel• QualityAssuranceManagersand

Personnel• LaboratorySupervisorsandPersonnel• ProcessingManagers• ComplianceProfessionals• LegalRepresentation

• Thesearethemostfarreachingregulationsforthetissueandcellindustry

• LearnhowtoreinforcecompliancewithyourQualitySystemsinspecificareas

• Learnhowotherindustrieshavebolsteredtheiremergencypreparednessprocedures

• Learnhowothershavedevelopedandimplementedtheirtrainingprograms

• BepreparedforanHCT/PEstablishmentInspectionandlearnhowbesttorespondto483Observations

• InterfacewithIndustryexpertsandFDA

WhoShouldAttend? WhyAttend?

AbouttheSpeakers

Ted Bender, RN, CTBS–Mr.BenderstartedhisTissueBankingcareeratThePennsylvaniaRegionalTissueBankin1986asatissuebanktechnician.Hewasresponsibleforeverythingfromconsent,tissueprocurement,processinganddistribution.Mr.Benderwasinthefirstclassin1989tobecomeanAATBcertifiedTissueBankSpecialist.In1998,PRTBmergedwithTheMusculoskeletalTransplantFoundation,andMr.BendermanagedtheprocessingsectionoftheJessupfacility.HewaspromotedtoDirectorofProcessingServicesin2007andpresentlyuseshis31yearsexperiencetohelpdeliverexceptionaltissuegraftstothesurgicalcommunity.

Katrina Carroll, BS–Ms.CarrollhasworkedforMTFBiologicsforoveradecade,movingfromaProjectManagementroleintoRegulatory.SheisresponsibleforthemanagementofallactivitiesintheRegulatoryAffairsDepartment,includingfunctionsrelatedtotheFDAandotherinternationalbodies,includingMedicalDeviceReporting,devicesubmissions,governmentallicensingandmanagingnonconformances.

Scott A. Brubaker, CTBS–Mr.BrubakerwasselectedinOctober2016asthenewDirector,DivisionofHumanTissues(DHT)intheOfficeofTissuesandAdvancedTherapies(OTAT)withintheCenterforBiologicsEvaluation&Research(CBER)attheFood&DrugAdministration(FDA).Priortothatheserved12yearsasSeniorVicePresidentofPolicyattheAmericanAssociationofTissueBanks(AATB)wheredutiesincludedoversightoftheAccreditationProgramandthedevelopmentandmanagementoftheAssociation’spolicies,professionalstandardsandguidancedocuments.BeforejoiningAATB,heacquired18yearsofpracticalexperienceinvolvingorgandonationandtissuebankingwhileholdingvariousmanagementpositionsatLifeNetinVirginiaBeach,Virginia.

Cindy Blinci, BA, MS, CTBS (AATB), CQA (ASQ)–Ms.BlinciistheQualityComplianceCoordinatorfortheColoradoCenterforReproductiveMedicine.HercurrentresponsibilitiesincludereviewingthirdpartyrecordsforFDAcompliance,conductingthirdpartysupplieraudits,employeetraining,SOPdevelopment,anddocumentcontrol.Priortothis,shewasaTissueSpecialistwithDohmenLifeScienceServices(formerlyReglera)andhasbeenservingtheHCT/Pindustrysince2002invariouscapacitiesincludingrecovery,familyservicesandqualityassurance.

Grace Bolton, BS, MS–Ms.BoltonistheValidationDirectoratLifeLinkTissueBank.ShehasbeenwithLifeLink11yearsandoverseesequipmentcalibration/qualification,processing/packaging/sterilizationvalidation/monitoringandenvironmentalmonitoring.ShereceivedaB.S.inMicrobiologyfromFloridaAtlanticUniversityandaM.S.inQualityAssurancealongwithaSixSigmaBlackBeltcertificationfromSouthernPolytechnicUniversity.Ms.BoltonhasservedontwoAATBTaskForces:MicrobialSurveillanceProgramandContainerandPackagingQualification/Validation.

Martin Browning, BS, MS–Mr.Browningisthepresidentandco-founderofEduQuest,Inc.Hehasover40yearsofFDAandregulatoryexperienceandwasoneofFDA’sfirstNationalComputerSystemsExperts.Hehasanddemonstratesextensiveexpertiseinmanagementconsulting,FDAregulation,regulatoryaffairs,qualityassurance,softwareandsystemsengineering,andauditing.Specificexperiencesincludequalitysystemsdesign,systemdesignassurance,verificationandvalidationofproductionandmanufacturingsystems,processesandsoftware.Mr.Browningisawell-knownexpertinFDAregulations,havingwrittenorcontributedtowritingseveralduringhisFDAcareer.

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Erica Agy, BS–Ms.Agystartedhercareerin2000inthepre-clinicalrealmprimarilyworkingwithnonhumanprimatesinbiomedicalresearch.Afterthreeyearsofhands-onanimalwork,shetransitionedtoQualityAssurance,whereshehassincefocusedherefforts.In2011,Ms.AgywasintroducedtotheworldofHCT/PproductswhenshewashiredbytheSeattleCancerCareAllianceasaQualityAssociate.Atthattime,herprimaryareaoffocuswasHCT/PproductdistributionfromtheCellularTherapyLaboratory.In2012,sheacceptedtheroleoftheQualityAssuranceComplianceSpecialist.HerresponsibilitiesincludeprovidingsupporttoboththeCellularTherapyLaboratory,aswellastheApheresisUnit,whichincludesdonorscreeningactivities,andthecollectionandprocessingof351and361HCT/Pproducts,andtheassessmentandreportingofHCT/PDeviationsandAdverseReactions.

AbouttheSpeakers

Susan Hurlbert, CEBT–Ms.Hurlberthas14yearsofexperienceineyebanking.ShejoinedEversightin2004,performingrecoveries,tissueevaluations,anddonoreligibility.In2013,shetransitionedtoaQualityImprovementrole.ShepresentlyservesastheClinicalOperationsSupervisorfortheBloomington,ILoffice,andisalsoresponsibleforallofEversight’sAdverseReactioninvestigationsandreporting.ShecurrentlysitsonEBAA’sMedicalReviewSubcommitteeandExamCommittee.

Kip J. Hanks, BS–Mr.HanksisaBiologicsNationalExpertforFDA’sOfficeofRegulatoryAffairs.HebeganemploymentwiththeAgencyin1997asageneralistinvestigatorinNewOrleans,LA.Overtheyears,hisworkfocusedonbiologicsandbioresearchmonitoring.HeservedasthedistrictbiologicsspecialistforNewOrleansandAtlantaDistrictsandwasselectedastheORAbiologicsnationalexpertin2011uponreturningtopost-HurricaneKatrinaNewOrleans.Inthisposition,InvestigatorHanksservesasaliaisonbetweenORAandCBER,trainsandmentorsbiologicsinvestigators,participatesonpolicyworkgroupsandcontinuestoperforminternationalinspections.

Jennifer DeMatteo, BS, MCM, CIC–Ms.DeMatteoistheDirectorofRegulationsandStandardsfortheEyeBankAssociationofAmerica.SheoverseestheEBAAAccreditationprogram,MedicalStandardsprocessandservesastheirregulatoryliaison.ShewasresponsiblefordirectingtheInfectionPreventionandControl(IPC)andEmployeeHealthprogramsandpersonnelatmajortertiaryhospitalandambulatorycaresettings.Ms.DeMatteohasbeenaHealthcareEpidemiologistforover20yearsandiscertifiedinInfectionControl&Epidemiology(CBIC).

La’ Tasha Gunter, BA, MS–Ms.GunterwashiredasaConsumerSafetyOfficerwiththeFDABaltimoreDistrictOfficeinFebruary2009.ShehasconducteddomesticHCT/P,bloodbank,donorcenter,testinglaboratory,drug,anddomestic/foreignfoodinspections.SheiscurrentlytheBiologicsSpecialistundertheOfficeofBiologicalProductsOperations/Division1.

Patricia Dahl, BS–Ms.DahlistheExecutiveDirector/CEOofTheEye-BankforSightRestorationinNewYorkandhas30yearsofexperienceineyebanking.SheisapastChairoftheEyeBankAssociationofAmericaandhasservedonavarietyofkeycommittees,includingitsMedicalAdvisoryBoard,AccreditationBoardandCertificationBoard.Additionally,sheisanactivememberoftheEuropeanAssociationofEyeBanks.SheisalsoamemberoftheNewYorkAllianceforDonation,astatewidecollaborativeorganizationestablishedtoincreaseawarenessfororgan,eyeandtissuedonation,andservesontheNewYorkStateTransplantCouncil.

Sejal Chitre, BE, ME–Ms.ChitreisaRegulatoryAffairsManageratMTFBiologics.Shehasbeeninthemedicaldeviceandtissuebankingindustryfor13years.PriortoworkingatMTF,Ms.ChitrewasaProcessEngineerforaMedicalDevicecompany.SheholdsaMastersofEngineeringdegreeinSystemsEngineering,aBachelorsofEngineeringDegreeinEngineeringManagementandaGraduateCertificateinPharmaceuticalManufacturingfromStevensInstituteofTechnologyaswellasaGraduateCertificateinRegulatoryAffairs–MedicalDevicesfromTheUniversityofSouthFlorida.

Brychan Clark, MD–Dr.ClarkreceivedherM.D.fromtheUniversityofMiamiSchoolofMedicinein1999andthencompletedherInternalMedicineresidencyfollowedbyafellowshipinInfectiousDiseasesattheSanAntonioUniformedServicesHealthEducationConsortium.Dr.ClarkretiredfromtheUnitedStatesAirForceasaLieutenantColonelin2015andthenjoinedtheFDAasaMedicalOfficerintheDivisionofHumanTissues,OfficeofTissuesandAdvancedTherapies,CenterforBiologicsEvaluationandResearch(CBER).

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AbouttheSpeakers

Lindsay Palomino, BSN, RN, HP(ASCP)–Ms.Palominohasbeenanurseforover20yearsinthefieldsofoncology,bonemarrowtransplantandapheresis.Shehasover18yearsofadultandpediatricclinicalapheresisexperience,includingfouryearsinthemedicaldeviceindustryprovidingcustomertechnicalsupportandtrainingforphotopheresis.ShehasbuiltanFDA/FACTcompliantapheresisprogram,implementedahealthydonorcellcollectionfacility,authoredtwoabstractsonapheresis,developedanapheresisnurseTrainingandCompetencyprogram,andimplementedaPediatricPhotopheresisProgram.Ms.PalominoiscurrentlytheNurseManagerofa6-bed/16-nurseApheresisunitattheSeattleCancerCareAllianceandisasubjectmatterexpertconsultantforabiopharmaceuticalcompany.

Michelle McClure, PhD–Dr.McClurehasbeenabiologistwithFDA’sOfficeofTissueandAdvancedTherapiesintheDivisionofHumanTissuesince2014.Herprimaryfocusispolicydevelopmentandregulatoryreviewasitrelatestoeligibilityofdonorsofhumancells,tissues,andcellularandtissue-basedproducts.PriortoobtainingaPh.D.ingenetics,Dr.McClureworkedinacardiovascularandorthopedictissueprocessinglaboratoryatabiotechnologycompany.

Ginette Y. Michaud, MD–Dr.GinetteMichaudisahematologistwith20yearsofregulatoryexperienceinbiologicalproductsandmedicaldevices.SinceMarchof2016,shehasservedastheDirectoroftheBiologicsProgramintheFDA’sOfficeofRegulatoryAffairs.PriortojoiningORA,Dr.MichaudwastheDeputyDirector,OfficeofBloodResearchandReviewintheCenterforBiologicsEvaluationandResearch.

Victoria (Tory) Lake, RAC, BA, BSc–Ms.LakeisthefounderofSoundRegulatoryConsulting,LLCwheresheoperatesasanindependentregulatoryaffairsconsultant.Sheoffersregulatorysupportandguidancetomanufacturingfacilitiesandclinicaltrialsponsorsutilizingnovelcelltherapyinvestigationalproductsandhematopoieticprogenitorstemcells,subjecttoFDA’sregulationsforcurrentGoodManufacturingPractices(CGMP)andcurrentGoodTissuePractices(CGTP).Previously,Ms.LakeservedastheRegulatoryAffairsDirectorforFredHutchinsonCancerResearchCenter.PriortothatsheservedastheAssociateDirectorofRegulatoryAffairsforabiologicscompanyfocusedonimmunotherapies.

Mary Malarkey, BS–Ms.MalarkeyistheDirectoroftheOfficeofComplianceandBiologicsQuality(OCBQ)intheCenterforBiologicsEvaluationandResearchattheUSFoodandDrugAdministration.OCBQisresponsibleforensuringthequalityofproductsregulatedbyCBERovertheirentirelifecyclethroughpre-marketreviewandinspection,andpost-marketreview,surveillance,inspection,outreachandcompliance.HerpreviouspositionsatCBERwereDirector,DivisionofCaseManagementfrom2000-2005andBranchChiefintheDivisionofManufacturingandProductQuality(DMPQ)from1996-2000.SheworkedinResearchandDevelopmentinindustrypriortojoiningFDA,andhasbeenwithCBERsince1989.ShedidlaboratoryworkinboththeOfficeofTherapeuticsResearchandReviewandOfficeofBloodResearchandReviewpriortobecomingafulltimereviewerin1993.

Kristin Mathes, BA, MA–Ms.Mathesbeganworkingineyebankingin1999inColorado.Sheperformedrecoveries,tissuesuitabilityevaluations,determineddonoreligibility,andplacedtissueforsurgery.In2007shelefttoworkforamedicaldevicecompanyintheRegulatoryAffairsdepartment.In2008,shemovedtoOregonandbeganworkingatLionsVisionGift.Inhercurrentrole,sheisresponsibleforoversightofLVG’sQualityProgramandeligibility/tissuereleasedepartments.

Stephanie Chea Matias, BS, MS–Ms.MatiasistheManagerofQualityEngineeringatMTFBiologics.Someofherresponsibilitiesinthisroleincludemanagementofthevalidationprogram,riskmanagementprogram,andexternallaboratories.Additionally,shehasdirectinteractionwithmajorfederalregulatoryagencies,bothforeignanddomestic.Ms.Matiashas10yearsofQualityexperienceinthemedicaldevicefieldandholdsaBachelor’sandMaster’sdegreeinBiomedicalEngineeringfromNJIT.

Safa Karandish, BS, MT(ASCP)–Ms.KarandishisaConsumerSafetyOfficerwithFDA’sOfficeofTissuesandAdvancedTherapiesintheDivisionofHumanTissues.ShejoinedFDAin2010,andherprimaryfocusisrelatedtopolicy,regulationsandreviewofcellulartherapyproducts.Ms.Karandishhasextensivecellulartherapyexperienceinbothacademicandindustrysettings.

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AbouttheSpeakers

Simone Porter, MD, MPH–Dr.PorterreceivedhermedicaldegreefromWeillCornellMedicalCollegeandmasterofpublichealthfromColumbiaUniversity’sMailmanSchoolofPublicHealth.SheistrainedasapediatricianfromDukeUniversityMedicalCenterandasapreventivemedicinephysicianfromMaryland’sDepartmentofHealthandMentalHygiene.ShejoinedtheFDADivisionofHumanTissueswithintheOfficeofTissuesandAdvancedTherapiesin2013.

Joel Reynolds, MLS (ASCP)CM, CQA (ASQ)–Mr.ReynoldsistheDirectorofQualityandRegulatoryAffairsforCaliforniaCryobank.HiscurrentresponsibilitiesincludeoversightoverCaliforniaCryobankanditssubsidiaries’regulatoryfunctions,safety,recordsmanagement,andqualitysystems.Hehas15yearsofexperienceworkinginqualityandregulatorycomplianceandasaMedicalLaboratoryScientistwithinthebloodbanking,tissuebanking,pharmaceutical,andmedicaldeviceindustries.

Debbie Seem, RN, MPH–Ms.SeemisaPublicHealthAnalystintheOfficeofHIV/AIDSandInfectiousDiseasePolicywithintheHHSOfficeoftheAssistantSecretaryforHealth.HerworkmainlyfocusesonissuesrelatedtotissuesafetyidentifiedbytheHHSAdvisoryCommitteeonBloodandTissueSafety.Previously,asaPublicHealthAdvisorintheCDCOfficeofBlood,OrganandotherTissueSafety,shesupportedinvestigations,researchandpublichealthinterventionstoimprovepatientsafetyrelatedtotransplantation.

Craig L. Sincaglia, BS–Mr.SincagliaistheManagerofProcessEngineeringatMTFBiologics.Hehas19yearsofprofessionalexperienceworkingoncontinuousprocessimprovement.Inadditiontoleadingtheprocessingengineeringandtrainingteams,Mr.SincagliatrainsandleadsLEANandcontinuousimprovementinitiatives.HeisanASQCertifiedSixSigmaBlackBelt,holdsaB.S.inChemicalEngineeringfromNJITandAdvancedMasterCertificateinLeanSixSigmaandLeanSixSigmaMasterBlackBeltcertificationfromVillanova.

Kathleen Swat, BA, BS–Ms.SwatisaBiologicsSpecialistInvestigatorwiththeFDAOfficeofRegulatoryAffairsandisresponsibleforconductingon-siteinspectionsofbiologicsfirms.SheworksoutoftheStLouis,MissouriresidentpostofficeandhasbeenwiththeFDAforover15years.PriortojoiningFDA,sheworkedasadietitianinpublichealthandspecializedinnutritionandHIV/AIDS.

Randall J. Thoma, PhD–Dr.ThomaiscurrentlythePrincipalatVeeSquaredConsultingServices.PriortoformingVeeSquared,hewastheAssociateDirectorofQualityAssuranceforZimmerBiologics,andhealsodevelopedandvalidatedprocessesforthemanufactureofmechanicalheartvalves.Dr.ThomaservedontheAATBAccreditationCommittee,isapast-Chairofthecommittee,andisalsocurrentlyaninspectorfortheAATBAccreditationorganization.

Wendy Wangsgard, PhD, RM(NRCM)–Dr.WangsgardhasbeenwithNelsonLaboratoriesfor13yearsandiscurrentlyaSeniorScientist,providingguidanceontestingandregulatoryissues.SheisamemberoftheAssociationfortheAdvancementofMedicalInstrumentation(AAMI)involvedintheworkinggroupsforRadiationSterilization,MicrobiologicalMethods,AssuranceofSterility,SterilizationTerminologyandtheCompatibilityofMaterialsSubjecttoSterilization.Dr.WangsgardisalsoamemberoftheAmericanAssociationofTissueBanks(AATB).

Jeffrey Wilson, BS–Mr.WilsonistheAssistantDirectoroftheMDAndersonCordBloodBank.Hehas20yearsofexperienceworkinginthestemcellfield,specializingincGMPcompliantmanufacturing.Inhiscurrentpositionheisresponsibleforoversightoftheday-to-dayoperationsofthecordbloodbankprogramandcGMP/ISO7manufacturingfacility.Previously,Mr.WilsonmanagedthecGMPmanufacturinglaboratoryatBaylorCollegeofMedicine’sCenterforCellandGeneTherapy.

Craig Zinderman, MD, MPH–Dr.ZindermanistheAssociateDirectorforProductSafetyintheDivisionofEpidemiology(DE),OfficeofBiostatisticsandEpidemiologyatFDA’sCenterforBiologicsEvaluationandResearch.HehasservedasaMedicalOfficerinDEsince2004,initiallyintheTherapeuticsandBloodSafetyBranch.PriortojoiningFDA,Dr.ZindermanservedasaPreventiveMedicineOfficerintheUSNavy.HeisBoardcertifiedinGeneralPublicHealthandPreventiveMedicine.

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Monday, February 5, 2018Morning Session: Moderator – Victoria Lake

8:00 – 9:00 Registration* 9:00 – 9:10 Welcome* 9:10 – 9:30 Personal Interest Story Related to HCT/Ps To Be Introduced9:30 – 9:50 FDA Update Scott Brubaker, FDA, CBER, OTAT, DHT9:50 – 10:10 FDA Adverse Reaction Reporting Craig Zinderman, MD, MPH, FDA,

CBER, OBE, DE10:10 – 10:55 Donor Eligibility Updates Michelle McClure, PhD, FDA, CBER,

OTAT, DHT, HTRB10:55 – 11:15 Break* 11:15 – 11:45 Compliance Update Mary Malarkey, FDA, CBER, OCBQ11:45 – 12:15 Inspectional Observations Kip Hanks, FDA, ORA12:15 – 1:30 Lunch*

Afternoon Session: Moderator – Victoria Lake

1:30 – 3:00 Emergency Preparedness Panel Debbie Seem, OASH Cells: Jeffrey Wilson Eye: Patricia Dahl Tissue: Ted Bender Tissue: Grace Bolton3:00 – 3:20 Break* 3:20 – 4:50 Workshop 1: Donor Eligibility and Moderators: Exemption Requests Brychan Clark, MD, FDA, CBER, OTAT, for Reproductive HCT/Ps DHT, HTRB and Simone Porter, MD, This workshop will cover making an MPH, FDA, CBER, OTAT, DHT, HTRB appropriate donor eligibility determination for donors of reproductive HCT/Ps. Discussion Brychan Clark, MD, FDA, CBER topics will include the current regulatory Simone Porter, MD, MPH, FDA, CBER requirements for donor screening and testing, Cindy Blinci when an exception to the 1271 regulations Joel Reynolds apply, and when an exemption should be requested. Case scenarios will be provided for discussion.

Workshop 2: Moderator: Adverse Reaction Reporting Jennifer DeMatteo This workshop will cover the investigation and current regulatory requirements for reporting Erica Agy adverse reactions, including 1271.350(a). Susan Hurlbert Speakers will present scenarios for different Stephanie Matias HCT/P types and discuss the reportability of Craig Zinderman, MD, MPH, FDA, Adverse Reactions. CBER, OBE, DE

Agenda

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Tuesday, February 6, 2018Morning Session: Moderator – Jennifer DeMatteo

9:00 – 9:20 Personal Interest Story Related to HCT/Ps To Be Introduced9:20 – 9:35 351/361 Regulatory Framework Scott Brubaker, FDA, CBER, OTAT, DHT9:35 – 10:05 ANSI/AAMI/ISO/U Wendy Wangsgard, PhD (American National Standards Institute/Association for the Advancement of Medical

Instrumentation/International Organization for Standardization/You)10:05 – 10:25 Break* 10:25 – 11:30 Computer Systems/Software Validation Kathleen Swat, FDA, ORA Martin Browning11:30 – 11:50 Quality Program – Personnel La’ Tasha Gunter, FDA, ORA11:50 – 12:15 Question and Answer Session Morning Speakers12:15 – 1:20 Lunch*

Afternoon Workshops

1:30 – 3:00 Workshop 1: Moderator: Training and Personnel: La’ Tasha Gunter, FDA, ORA Tailored Programs for Diverse Needs This workshop will cover how HCT/P industries Kristin Mathes design and implement their training programs. Lindsay Palomino Discussion topics will include how organizations Craig Sincaglia of varying size implement appropriate programs for recovery, processing, and other core cGTP functions. Examples of tools used for training will be presented.

Workshop 2: Moderator: Responding to 483 Observations Kip Hanks, FDA, ORA This workshop will include “real” 483 observations made during an HCT/P Industry: Randall Thoma, PhD Establishment Inspection, where participants will have the opportunity to design the best Facilitators: response to a 483 observation. Observations Cells: Erica Agy will include those related to quality program Eye: Susan Hurlbert requirements (1271.160) as well as core cGTPs, Tissue: Stephanie Matias including recovery, processing, and donor eligibility.

3:00 – 3:20 Break* 3:20 – 4:50 Workshops repeated

Agenda

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Agenda

Wednesday, February 7, 2018Morning Session: Moderator – Kip Hanks, FDA, ORA

9:00 – 9:10 Workshop Reports (key discussion and take-aways) 9:10 – 9:30 FDA/ORA’s Program Alignment Reorganization Ginette Michaud, MD, FDA, ORA,

OBPO9:30 – 10:10 Considerations for International Distribution Katrina Carroll Sejal Chitre10:10 – 10:30 Break* 10:30 – 11:30 Ask the FDA FDA Personnel

*Denotes non-educational activity

ContinuingEducation This conference qualifies for 13.0 hours of continuing education credit.

The Westin Alexandria is conveniently located two Metro stops or a 15-minute taxi ride from Reagan International Airport. From the Metro stop it is a 10-minute walk or the hotel will come pick you up. Seated on the Potomac, Alexandria is a historic community known for its rich history and beautifully preserved 18th and 19th century architecture, not to mention its quaint boutiques and inviting restaurants. Discover Alexandria’s historic Old Town, eclectic Del Ray, innovative Carlyle

and the diverse West End or visit DC just 25 minutes away. Highlights in the area are Mt. Vernon, the George Washington Masonic National Memorial and George Washington Estate and Gardens.

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14th AnnualFDA and the Changing Paradigm for HCT/P Regulation

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