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Program 2016

Day 1

22 September 2016, 09:00 - 18:00
Institute of Pharmacology, First Faculty of Medicine, Charles University in Prague, Albertov 4, 128 00 Praha 2, Czech Republic

8:30 - 9:00 Registration

9:00 Fixed dose combinations - regulatory perspective and update (Ondřej Slanař, Radka Montoniová)
9:45 Fixed dose combinations - industry perspective (Jiří Hofmann)
10:30 Coffee Break

10:45 Two-stage sequential designs - industry perspective (Helmut Schütz)
11:30 Adaptive designs - pilot/pivotal PK studies (Liz Allen)
12:15 NTI drug (Patrick Nicolas)
13:00 Lunch at Potrefená Husa Albertov

14:15 Two-stage sequential designs - regulatory perspective (Helmut Schütz)
15:00 Biowaivers from industry perspective MR products (Yu San Wu)
15:45 Coffee Break

16:00 Strength biowaivers industry perspective IR products (Andrzej Dzierbicki)
16:45 Strength biowaivers jurisdiction differences (Barbara Davit)

23 September 2016, 09:00 - 13:00
Institute of Pharmacology, First Faculty of Medicine, Charles University in Prague, Albertov 4, 128 00 Praha 2, Czech Republic

9:00 How to deal with the matrix effect (Miroslav Ryska)
9:45 Introduction to the IVIVC (Jean Michel Cardot)
10:30 Coffee Break

10:45 Implementing IVIVC in development of orally inhaled products (Vít Perlík)
11:30 IVIVC pitfals (Jean Michel Cardot)
12:15 Use of PK modeling in the development (Paula Muñiz)
13:00 Lunch at Potrefená Husa Albertov