23rd 3rd Bioequivalence Conference 2025
26 February 2025
Hilton Amsterdam Airport Schiphol
Amsterdam, The Netherlands
Medicines for Europe 3rd Bioequivalence Conference 2025
Home/Conferences | Posted 20/11/2024 0 Post your comment
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 event is scheduled to take place on 26 February 2025, at the Hilton Amsterdam Airport Schiphol Hotel in The Netherlands and will be held in person.
The conference will provide a platform for exchanging views among industry representatives, regulators, and academia. It 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
Join us in Amsterdam in these very special times for bioequivalence and participate in our lively discussions!
For more details, visit: www.medicinesforeurope.com/bioeq25
Guidelines
Regulatory update for post-registration of biological products in Brazil
New regulations in Brazil for the registration of biosimilars
Policies & Legislation
NPRA Malaysia trials new timelines for variation applications
Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US
Comments (0)
Post your comment