2017
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Day 1 – 21. 9. 2017
Institute of Pharmacology | First Faculty of Medicine | Charles University in Prague | Albertov 4, 128 00 Prague 2 | Czech Republic
Morning session 1 (9:00–10.30, 2 x 45 min) BCS Biowaivers
Slot 1 Henrike Potthast (BfArM): BCS-based biowaivers between different regions, product specification
Slot 2 Pieter Guelen (PCS): The use of biowaivers in real practice - industry perspective
Coffee Break (10.30–11:00)
Morning session 2 (10.30–11.00, 2 x 45 min) Regulatory Update on important topics
Slot 1 Marina Feřtek (SÚKL): Fixed dose combinations
Slot 2 Milena Stain (AGES): Biosimilars
Lunch (12.30 - 14:00)
Afternoon session 1 (14:00–15.30) In vitro/In silico as in vivo surrogate
Slot 1 Sandra van Os (Synthon): Draft guideline on locally applied and acting drugs in GIT (in vitro/in vivo)
Coffee Break (15.30–16:00)
Afternoon session 2 (16:00–17.30, 2 x 45 min)
Slot 1 Helmut Schütz (BEBAC): How to design a pilot study - extrapolation of results
Slot 2 Vit Perlik (Consultant): Regulatory Year in review - new draft guidelines
Day 2 – 22. 9. 2017
Institute of Pharmacology | First Faculty of Medicine | Charles University in Prague | Albertov 4, 128 00 Prague 2 | Czech Republic
Morning session 1 (9:00–10.30, 2 x 45 min) Dissolution
Slot 1 Ivana Taševská (SÚKL): Reflection paper on dissolution limits
Slot 2 Jiri Hofmann (Sanofi/Zentiva): Reflection paper on dissolution specification for generics
Coffee Break (10.30–11:00)
Morning session 2 (11:00–12.30, 2 x 45 min)
Slot 1 Paula Muñiz (Dynakin): Time scaling in IVIVC
Slot 2 Jean Michel Cardot (Université d'Auvergne): IVIVC common problems and regulatory acceptability
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