regulatory affairs 2016 tentative program
TRANSCRIPT
6th International Conference and Exhibition on
Pharmaceutical Regulatory Affairs and IPR Sep 29-30, 2016 Orlando, USA
Tentative Program
Hosting Organizations: Conference Series LLC
2360 Corporate Circle, Suite 400 Henderson, NV 89074-7722, USA
Tel: +1-702-508-5200 Ext: 8044, Fax: +1-650-618-1417, Toll free: +1-800-216-6499
Conference Series Ltd
Heathrow Stockley Park Lakeside House, 1 Furzeground Way,
Heathrow, UB11 1BD, UK, Tel: +1-800-216-6499
Email: [email protected]; [email protected]
Page 2
08:30-09:30 Registrations
Hall
09:30-09:55
Opening Ceremony
Speaker Talks
Title: Current FDA Audit Trends and Most Common Cited Drug GMP Deficiencies
Kenneth Christie, VTS Consultants, Inc., USA
Title: Regulatory submissions and quality considerations for combination drug/ device products: a primer
David Amor, Medgineering Inc., USA
Title: The Regulatory Affairs as a bridge between Government Regulatory Authorities and Pharmaceutical Companies
Elene Chikobava, Quadrium Pharmhouse Ltd., Georgia
Title: Localization of Foreign Medicinal Products Manufacturing in Russia
Mohammad Shahbaz Alam, Meher Pharma, India
Title: Strengthening Regional Collaboration among ASEAN Regulatory Laboratories to Ensure Quality Assurance in Pharmaceuticals
Maria Soledad L. Distor, Philippine Accreditation Bureau, Philippines
Title: Pharmaceutical Industry in India after TRIPS
S.K Tannan, Lovely Professional University, India
Title: Cleaning Validation in Pharmaceuticals
Rashid Mahmood, Surge Laboratories Private Limited, Pakistan
Title: Effects of Histone Deacetylase Inhibitors on Anti Neo Plastic Activity
Juhi Tiwari, Jayoti Vidyapeeth Women’s University, India
Title: Survey on awareness, perception, and extent of usage of nutraceuticals and dietary supplement in local region of Uttar Pradesh, India
Nitesh Chauhan, KIET School of Pharmacy, India
Title: From pharmacogenetics to personalized medicine: A Cuban regulatory perspective
Remirez Diadelis, National Centre for State Quality Control of Drugs, Cuba
Title: Regulatory Framework in Cuba
Remirez Diadelis, National Centre for State Quality Control of Drugs, Cuba
Title: Regulatory status of herbal medicines. Considerations about Cuba and Latin America
Remirez Diadelis, National Centre for State Quality Control of Drugs, Cuba
Title: Cardiovascular effect of Nigella sativa L. aqueous extract in normal rats
Mohamed EDDOUKS, Moulay Ismail University, Morocco
Title: ABC-VEN matrix analysis of pharmaceutical inventory management in Tikur Anbessa Specialized Hospital for the years 2009 to 2013, Addis Ababa, Ethiopia
Sefinew Migbaru, Addis Ababa University, Ethiopia
Title: Regulatory requirements for Drugs & Cosmetics in India
Kalyan Chakravarthy Akula, Dr. Reddy’s Laboratories Limited, India
Young Researchers Forum
Title: Food Additives and Health
Mercy Ekwere, Cross River College of Education, Nigeria
Title: Influence of Medical Representatives on Prescribing Practice in Mekelle, Northern Ethiopia
Terefe Teshome, Mekelle University, Ethiopia
Day 1 Sep 29, 2016
Page 3
Keynote Speakers
Page 4
About Florida
Florida is a state in the southeastern region of the United States, bordered to the west by the Gulf
of Mexico, to the north by Alabama and Georgia, to the east by the Atlantic Ocean, and to the south
by the Straits of Florida. Florida is the 22nd most extensive, the 4th most populous, and the 8th most
densely populated of the 50 United States. The state capital is Tallahassee, the largest city is
Jacksonville, and the largest metropolitan area is the Miami metropolitan area.
Much of Florida is a peninsula between the Gulf of Mexico, the Atlantic Ocean, and the Straits of
Florida. Its geography is notable for a coastline, omnipresent water and the threat of hurricanes.
Florida has the longest coastline in the contiguous United States, encompassing approximately 1,350
miles and is the only state that borders both the Gulf of Mexico and the Atlantic Ocean. Much of the
state is at or near sea level and is characterized by sedimentary soil. The climate varies from
subtropical in the north to tropical in the south. Some of its most iconic animals, such as the
American alligator, crocodile, Florida panther and the manatee, can be found in the Everglades
National Park.
Florida was a challenge for the European colonial powers before it gained statehood in the United
States in 1845. It was a principal location of the Seminole Wars against the Indians, and racial
segregation after the American Civil War. Today, it is distinguished by its large Hispanic community
and high population growth, as well as its increasing environmental concerns. Its economy relies
mainly on tourism, agriculture, and transportation, which developed in the late 19th century.