Royal Pharmaceutical Society of Great Britain, London, London
Wednesday 22 – Friday 24 October 2008
09:00 Welcome Kamal K. Midha, FIP
09:05 Keynote address: Advances in understanding and assessment of BE during the last two decades: Achievements and Gaps. TBD Session 1: When are Clinical/Patient studies needed for Bioequivalence Assessment?
Moderators: Vinod P. Shah, FIP, USA and Lawrence Yu, FDA, USA
09:50 Cytotoxic drugs Rabi Patnaik, Watson Labs Inc., USA
10:20 An overview of BE of topical drugs: Where are we today? Vinod P. Shah, FIP, USA
10:50 Coffee break
11:10 BE of Topical drugs: Clinical approaches TBD
11:25 BE of Topical drugs: Alternative approaches Dennis Bashaw, FDA, USA
11:40 BE of Topical Drugs: Microdialysis and DPK Eva Benfeldt, University of Copenhagen, Denmark
12:00 Q and A
12:30 Lunch Session 2: When are Clinical/Patient studies needed for Bioequivalence Assessment?
Moderators: Gur Jai Pal Singh, Watson Labs Inc., USA and T.S. Purewal, Bespak, UK
13:30 Respiratory drugs – MDIs, DPIs Gur Jai Pal Singh, Watson Labs Inc., USA
14:00 Scientific and Clinical Considerations in Evaluation of Bioequivalence of Respiratory Drugs Badrul Chowdhury, FDA, USA
14:30 Device and Formulations Considerations for Pharmaceutical Equivalence of Inhalation Drug Products T. S. Purewal, Bespak, UK
15:00 Coffee break
15:30 Formulation Development for Equivalent Performance of Dry Powder Inhalers Robert Price, University of Bath, UK
16:00 Q and A Session 3: International BE Issues and Assessments
Moderators: Mitsura Hashida, Kyoto University and Kamal K. Midha, FIP
16:30 Evolving BE standards: Scientific challenges and regulatory opportunities Lawrence Yu, FDA, USA
17:00 India Surinder Singh, DGI, India
17:30 China Sang Guowei, Chinese Pharmaceutical Association, China Welcome reception and networking Thursday 23 October Session 4: International BE requirements and Comparator drug product
Moderators: Leon Shargel, Applied Biopharmaceutics, USA and Gordon Johnston, GPhA, USA
09:00 Survey of International Bioequivalence Requirements Henning Blume, Socratec, Germany
09:30 Maintaining the Quality of Multisource products around the world Lembit Rago, WHO, Switzerland
10:00 Use of an international reference listed drug product, RLD as a standard Identify the problem Leon Shargel, USA
10:30 Coffee break
10:50 Drug product approval and maintenance of quality of multisource products in Brazil Renata A. Dias, Sindusfarma, Brazil.
11:20 Case study: Maintaining the quality of multisource products in India Vinay Nayak, Watson Pharma Private Limited, India.
11:50 Q and A
12:20 Lunch Session 5: Transdermal Drugs – BE Issues
Moderators: Rabi Patnaik, Watson Labs Inc., USA
13:20 BE assessment of transdermal products – Current status and issues Gordon Johnston, GPhA, USA 13:50 Formulation development and Transdermal absorption: Prediction of drug absorption by in vitro testing Scott Gochnour, Watson Labs Inc., USA
14:20 Challenges or strategies in dev eloping newer generations/types of generic transdermal drug delivery systems TBD
14:50 Coffee Break Session 6: International Experience on BE Practice
Moderators: Kamal K. Midha, FIP and Gordon Johnston, GPhA, USA
15:10 Canada: Eric Ormsby, Therapeutic Products Directorate Greece: Panos Macheras Turkey: Yilmaz Capan Jordan: Laila Jarra, Head of Drug Directorate Spain: TBD India: TBD Korea: TBD Hungary: Hilda Koszegi-Szalai
18.00 Close of day Friday 24 October
09:00 Key note address: Does the Interplay of efflux transporters and metabolic enzymes in the GI tract have any effect on BE determination? Les Benet, University of California, USA Session 7: BCS Approach: Product Development
Moderators: Dirk Barends, National Institute for Public Health and the Environment, Netherlands and Mehul Mehta, FDA, USA
09:30 BCS approach in product development and assessment – Academic view point James Polli, University of Maryland, USA
10:00 BCS approach in product development and assessment – Industrial view point Bertil Abrahamsson, AstraZeneca, UK
10:30 Break
11:00 BCS Approach in product development and assessment – Regulatory view point Mehul Mehta, FDA, USA
11:30 Director of NICE
12:00 Summary of sessions
Chair: Vinod P. Shah and Kamal K. Midha
12:45 Q and A
13:45 Closing remarks. Vinod P. Shah
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