BioBridges 2023 [Conferences / Workshops]
![[image]](img/uploaded/image605.png)
reserve the days for BioBridges 2023 (September 20/21, Charles University, Prague, Czech Republic).
Main topics:
- Real world evidence / real world data
Key note lecture by Steffen Thirstrup (Chief Medical Officer of EMA) - ICH M13a update on comments
- Product specific guidelines
- Well Established Use (10a) – back to roots?
- Comparison of individual excipients, Q&A 3.12, BCS based biowaivers, questions from agencies
- GL on drug interaction – impact on FDCs
- Complex formulations / products (e.g., lanreotide, amphotericin B)
- Biosimilars – where we go in future (fast acting insulin, GLP1)
Jean-Michel Cardot, Vít Perlík, Helmut Schütz, and Ondřej Slanař
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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!
![[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
Complete thread:
- BioBridges 2023Helmut 2023-04-06 10:52 [Conferences / Workshops]📌