2016

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Institute of Pharmacology | First Faculty of Medicine | Charles University in Prague | Albertov 4, 128 00 Prague 2 | Czech Republic

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