Exiting News for Bioequivalence Professionals: 5th GBHI Conference Program is Updated

News of July 6th, 2022

Do not miss the 5th Global Bioequivalence Harmonization Initiative (GBHI) conference – the updated program is really promising.

The workshop will be held in September 2022 as a face-to-face event in Amsterdam, The Netherlands, with strong international participation. Mehul Mehta (FDA) and Barbara Schug (SocraTec R&D) will be the co-chairs for this conference, which is scheduled for September 28 and 29, 2022.

Please note: The early bird deadline is already July 10, 2022.

The updated program is now available online here and covers the following topics:

• Fed vs. fasted studies for immediate release dosage forms: relevance of excipients, disintegration/dissolution specificities, drug substance properties and physiological GI conditions – new findings shall help achieve harmonisation
• Statistical considerations for BE assessment: replicate design for BE of Highly Variable Drugs, two-stage design and PK modelling as supportive tools for BE assessment
• Topical products: Scientifically-based approaches for a waiver of clinical endpoint trials
• Narrow therapeutic index drugs: study design and acceptance criteria

This conference is held by EUFEPS in collaboration with AAPS, supported by the European Medicines Agency (EMA) as well as the U.S. Food and Drug Administration (FDA).

In the last years this series of workshops always provided a forum for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on selected BE issues in the hope of identifying common ground and arriving at a harmonized view on these topics.

Since we know that several of our partners and customers appreciated the interesting presentations and discussions, attending these conferences during the last years, we wanted to share the new dates and the updated program with you.

We from SocraTec R&D look forward to this workshop and hope to see you there!