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Workshop Summary
For several years now, the European Federation for Pharmaceutical Sciences (EUFEPS), with its Network on Bioavailability and Biopharmaceutics (BABP) in the lead, has worked toward harmonizing the requirements for bioequivalence assessment. This goal was encouraged from the beginning by the European Medicines Agency (EMA) as well as the US Food and Drug Administration (FDA). To support the intended process of global harmonization scientifically, a series of international conferences was started by EUFEPS in collaboration with AAPS. The first one was held in 2015 in Amsterdam/The Netherlands, followed by a second one in 2016 in Rockville/USA, and a third one in 2018 again in Amsterdam. All conferences were characterized by open discussions and constructive exchange between regulatory scientists, academia and industry. Thus, these contributed significantly to the debate on a worldwide harmonization of bioequivalence requirements. Also regulators and speakers from other countries/regions, e.g. Canada, Chile, China, India, Japan, Jordan, Mexico, and Brazil, attended and contributed to the discussions. Such global participation has formed an ideal platform for scientists from the pharmaceutical industry and academia to exchange their experience and views with regulators. Scientific consensus achieved at the end of processes such as these should constitute the most appropriate basis for harmonization.
In order to disseminate the outcomes most widely, conference reports have been compiled. The first two have been published in the
European Journal of Pharmaceutical Sciences and the third is in preparation.
Participants of this event will:
- Receive a summary of the outcome of the sessions from the last conference and have an opportunity to provide input for further harmonization on these topics. This may also include preliminary discussion regarding the definition of a Global Reference Product.
- Get an overview of the similarity and differences in BE considerations for implants / long-acting injectables across major regulatory agencies, and join the discussions towards, development of similarity in approaches.
- Find out the current BE requirements for orally inhaled products for major regulatory agencies, and a scientific critique of these from academic and industry experts.
- Join the discussion regarding the pros and cons of the necessity of fed BE studies for immediate release oral dosage forms with regulatory, industry, and academic scientists.
- Get an in-depth understanding of how to design complex BE programs that would be viewed positively across all major regulatory regions.
Conference ChairsHenning Blume, Ph.D., SocraTec C&S
Mehul Mehta, Ph.D., FDA
Scientific Planning CommitteeGerald Beuerle, Ph.D., ratiopharm
Henning Blume, Ph.D., SocraTec C&S,
Angelica Dorantes, Ph.D., FDA
Georg Hempel, Ph.D., University of Münster
Wenlei Jiang, Ph.D., FDA
Andreas Kovar, Ph.D., Sanofi
Mehul Mehta, Ph.D., FDA
Henrike Potthast, Ph.D., BfArM
Gustavo Mendes Lima Santos, Ph.D., ANVISA
Barbara Schug, Ph.D., SocraTec R&D
Anne Seidlitz, Ph.D., University of Greifswald
Nilufer Tampal, Ph.D., FDA
Yu-Chung Tsang, Ph.D., Apotex
Jan Welink, Ph.D., MEB