2016

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Day 1 – 22. 9. 2016

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 restaurant 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)

18:30 Networking dinner at restaurant Potrefená Husa Albertov

Day 2 – 23. 9. 2016

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 restaurant Potrefená Husa Albertov