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)
Slot 2 Jean Michel Cardot (Université d'Auvergne): Reflection paper on Modeling, statistical methodology used for drug development

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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