Bioequivalence and Bioavailability Forum

Dear all,

reserve the days for BioBridges 2023 (September 21/22, Institute of Physiology, First Faculty of Medicine, Charles Uni­ver­sity, Albertov 5, Prague 2, Czech Republic).*

Main topics:

• M13 update on comments
  
• RWE/RWD – real-world evidence / real-world data
  
• Product specific GDLs
  
• Clinical pharmacology and pharmacokinetics: questions and answers
  
• Comparison of individual excipients, BCS-based biowaivers, questions from Agencies
  
• Well Established Use (10a) – back to roots
  
• Guideline on drug interaction – impact on FDCs
  
• Complex formulations/products (e.g., lanreotide, amphotericin B)
  
• Biosimilars – where we go in future (e.g., fast-acting insulin, GLP1)

Program

Kind regards,
Jean-Michel Cardot, Vít Perlík, Helmut Schütz, and Ondřej Slanař for the
BioBridges Workshop Team

---

• The venue is 70 m across the street from the one of previous conferences (Institute of Pharmacology, Albertov 4;
  lower left corner in the map).