2022
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DAY 1 (September 22, 2022)
9:00–10:30 Morning session 1
Biosimilars and orphan medicinal product development
Rene Anour (AGES)
Improvement of PK drug properties – development and regulatory perspective
Tomáš Hauser (Zentiva)
11:00–12:30 Morning session 2
ICH M13 BES harmonization – basic prerequisites
Susana Almeida (Medicines for Europe)
EMA News in dissolution 2020–2022
Jean-Michel Cardot (Consultant)
14:00–15:30 Afternoon session 1
Untangling absorption mechanisms and variability in bioequivalence studies using population analysis
Nuno Silva (Universidade de Lisboa)
Locally applied Locally acting in GIT – biowaivers
Jean-Michel Cardot (Consultant)
16:00–17:00 Afternoon session 2
Locally applied, locally acting products
Flavian Radulescu (University of Medicine and Pharmacy)
DAY 2 (September 23, 2022)
9:00–10:30 Morning session 1
Product specific guidelines – Tmax criteria
Graham Pennick (Reckitt Benckiser)
Tmax evaluation – where do we go…
Helmut Schütz (BEBAC)
11:00–12:30 Morning session 2
Partial AUCs – tool for development vs regulation
Vít Perlík (BioBridges, Consultant)
Loice Kikwai (Consultant)