AGENDA

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 (9h - 10.30h, 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 (10.30h - 11h)

Morning session 2 (10.30h - 11.00h, 2 x 45 min) Regulatory Update on important topics
Slot 1 Marina Feřtek (SÚKL): Fixed dose combinations
Slot 2 Milena Stain (AGES): Biosimilars

  • Lunch (12.30h - 14h)

Afternoon session 1 (14h - 15.30h) 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 (15.30h - 16h)

Afternoon session 2 (16h - 17.30h, 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 (9h - 10.30h, 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 (10.30h - 11h)

Morning session 2 (11h - 12.30h, 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

MEETING END

  • Lunch (12.30h - 14h)