GBHI 2022 – 5th Annual Global Bioequivalence Harmonization Initiative Meeting

The goal of the Global Bioequivalence Harmonization Initiative (GBHI) conference is to offer the most informative and up to date science and regulation of bioequivalence in global drug development.

The FDA AAPS EUFEPS 5th Annual GBHI Meeting will be held 28-29 September 2022. GBHI workshop provides an open forum for pharmaceutical scientists from academia, industry and regulatory agencies to discuss various bioequivalence topics at issue including:

• Fed vs fasted studies for immediate release dosage forms
• Relevance of excipients, disintegration/dissolution specificities, drug substance properties and physiological GI conditions
• Replicate design for BE of Highly Variable Drugs
• two-stage design and Pharmacokinetic modelling as supportive tools for BE assessment
• Scientifically-based approaches for a waiver of clinical endpoint trials
• Study design and acceptance criteria

This conference is intended for leaders in Academia, the Pharmaceutical and Biotechnology Industry (PhRMA, BIO, GPhA), contract research organizations, API manufacturers, and domestic and international regulatory agencies in positions to affect the science and regulation of drug discovery and development, who wish to stay abreast of the national and international initiatives affecting the development of safe and effective pharmaceutical drug products.

Please visit the FDA’s Global Bioequivalence Harmonization Initiative (GBHI) conference website for more information.