GBHI Conference Series

Scope and aim
Since decades, bioequivalence is considered one of the key questions in new and generic drug product development and registration worldwide. At the same time, it is obvious that the regulations and jurisdictions still differ to certain extent from country to country and continent to continent, although the scientific basis for it is globally the same. This aspect, and the on-going discussion on the suitability of reference products purchased from a specific country and their applicability for submissions in other countries or regions, create the necessity to conduct several only slightly different bioequivalence studies to get the same product authorised in various markets.
Networking Initiative
In order to contribute to improving this situation and acknowledging the benefit of previous conferences addressing certain aspects of controversies in BE assessment, EUFEPS (the European Federation for Pharmaceutical Sciences), with its Network on Bioavailability and Biopharmaceutics (BABP) in the lead, have agreed to set up a conference starting the Global Bioequivalence Harmonisation Initiative (GBHI). Accordingly, specific topics should be listed for scientific discussion, the intention being to identify common ground and arrive at a harmonised view among all parties involved.

In March 2015 the network organised the First International Conference of the Global Bioequivalence Harmonisation Initiative (GBHI) in Amsterdam together with international scientists and regulators worldwide including Europe, USA and Asia. The second International Conference of GBHI was realized together with AAPS in Washington in September 2016. The third meeting was held in April 2018 in Amsterdam and the 4^th meeting in December 2019 in Washington. The work continued with the 5^th GBHI meeting in Amsterdam in September 2022.