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RegisterMedicines for Europe: 2nd BE Workshop [Conferences / Workshops]
posted by Helmut 
– Vienna, Austria, 2022-12-10 10:43 (112 d 19:35 ago) – Posting: # 23396
Views: 1,439
Dear all,
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:
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!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Medicines for Europe: 2nd BE WorkshopHelmut 2022-12-10 09:43 [Conferences / Workshops]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Medicines for Europe: 2nd BE Workshop ElMaestro 2022-12-10 14:48
- Medicines for Europe: 2nd BE Workshop SMA 2023-01-18 09:48
Ing. Helmut Schütz