Vienna, Austria,
2023-04-06 12:52
(52 d 09:24 ago)

Posting: # 23522
Views: 972

 BioBridges 2023 [Conferences / Workshops]

[image]Dear all,

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)
Kind regards,
Jean-Michel Cardot, Vít Perlík, Helmut Schütz, and Ondřej Slanař
BioBridges Workshop Team [image] [image] [image] [image]

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

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