The landscape of bioequivalence guidelines is evolving, with significant progress being made in the ICH M13 guideline series and in global regulatory harmonisation.
While regional/national authorities determine the implementation strategy in their respective regions, Medicines for Europe and the International Generic and Biosimilar medicines Association (IGBA) will gather leading international experts together for the 3rd Bioequivalence Conference. This is scheduled to take place on 26th February 2025, at the Hilton Amsterdam Airport Schiphol Hotel, The Netherlands and will be an in-person event.
The conference will provide a platform for an exchange of views between industry, regulators, and academia and will cover the following topics:
- Single global development of generic medicines: enabling patient access
- International harmonisation of bioequivalence: the current status and next steps (ICH M13A implementation and hot topics for M13C)
- Model-informed approaches supporting bioequivalence in generic medicines development
- Data integrity in bioequivalence studies