EUFEPS/AAPS Global Bio Equivalence Harmonization Initiative: 5th International Workshop – GBHI 2022

The Global Bioequivalence Harmonization Initiative is intended to support the process of global harmonization via scientific discussion among international stakeholders. Therefore, a series of international conferences were 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, the pharmaceutical industry, and academia to exchange their experience and scientific viewpoints: scientific consensus should constitute the most appropriate basis for harmonization.

Simulations Plus Associate Vice President, Regulatory Affairs Xavier Pepin will be in attendance.