5th conference on The Global Harmonization Initiative



5th conference on

The Global Harmonization Initiative,

September 28 – 29, 2022 • Amsterdam• Netherlands


The topics of the next conference have been fixed:
•Fed vs fasted studies for immediate release dosage forms: relevance of excipients,disintegration/dissolution specificities, drug substance properties and physiologicalGI    conditions - new findings shall help achieve harmonisation
•Statistical considerations for BE assessment: replicate design for BE of Highly VariableDrugs, two-stage design and PK modelling as supportive tools for BE assessment
•Topical products: Scientifically-based approaches for a waiver of clinical endpointtrials
•Narrow therapeutic index drugs: study design and acceptance criteria

The Global Bioequivalence Harmonisation Initiative is intended to support the process of global harmonization via scientific discussion among international stakeholders. Therefore, a series of international conferences was founded by EUFEPS in collaboration with AAPS supported from the beginning by the European Medicines Agency (EMA) as well as the U.S. Food and Drug Administration (FDA).
Regulators and speakers from other countries/regions, e.g., Canada, Chile, China, India, Japan, Jordan, Mexico, and Brazil, will be invited to the discussions. Such global participation presents an ideal platform for scientists from regulatory agencies, pharmaceutical industry and academia to exchange their experience and scientific viewpoints: scientific consensus should constitute the most appropriate basis for harmonization.
The Organising Committee of the 5th GBHI Workshop is now presenting the topics, date and venue of the next conference. After the 4th conference in Washington in 2019, now
Amsterdam has again been selected as the location.


Workshop Planning Committee
Mehul Mehta, Ph.D., U.S. Food and Drug Administration (co-chair)
Barbara S. Schug, Ph.D., SocraTec R&D GmbH (co-chair)
Gerald Beuerle, Ph.D., Teva
Erem Bilensoy, Hacettepe University
Henning Blume, Ph.D., SocraTec C&S GmbH
Jack Cook, Ph.D., Pfizer
Sebastian Haertter, Ph.D., Boehringer Ingelheim Pharma GmbH & Co. KG
Georg Hempel, Ph.D., University of Münster
Wenlei Jiang, Ph.D., U.S. Food and Drug Administration
Janet König, M.D., Bundesinstitut für Arzneimittel und Medizinprodukte
Andreas Kovar, Ph.D., Sanofi
Anne Seidlitz, Ph.D., University of Greifswald
Nilufer Tampal, Ph.D., U.S. Food and Drug Administration
Yu-Chung Tsang, Ph.D., Apotex
Jan Welink, Ph.D., Medicines Evaluation Board


Please visit the conference webpage for more information: https://gbhi.eufeps.org/


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