Bioequivalence and Bioavailability Forum

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