Bioequivalence and Bioavailability Forum

BioBridges 2023 [Conferences / Workshops]

posted by Helmut  – Vienna, Austria, 2023-04-06 12:52 (52 d 08:08 ago) – Posting: # 23522
Views: 970

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

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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• BioBridges 2023Helmut 2023-04-06 10:52 [Conferences / Workshops]📌