Medicines for Europe: 2nd BE Workshop [Conferences / Workshops]
Medicines for Europe is organizing its 2nd Bioequivalence Workshop on April 26th, 2023 in Brussels. The program is still being developed but is expected to cover:
- International convergence and reliance
- ICH M13*
- Model informed drug development and virtual BE
- Implementation of M10 from the European perspective
- Compliance and oversight in BE
- Step 2a/2b endorsement of the first draft guideline in the series (M13A focusing on BE study considerations of IR formulations and data analysis for a non-replicate study design); start of public consultation planned for December 2022.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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