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PSDM Workshop: Recent draft ICH/ CPMP Guidelines revisited
Date February 3, 2005
Location Yamanouchi Europe, Leiderdorp
Organisation PSDM

Program:

13:00 ÷ 13:30 Registration and coffee
13:30 ÷ 13:35 Welcome and introduction
Gonnie van Osta (PSDM main committee), N.V. Organon, Oss
13:35 ÷ 14:30 Does the PtC provide Guidance on the Choice of Non-inferiority margin as promised by its Title?
Egbert Biesheuvel (EFSPI rapporteur of PtC on Choice of delta), NV Organon, Oss
14:30 ÷ 15:30 ICH guideline E14 on QTc prolongation
Georg Ferber (EFSPI rapporteur of ICH E14 on QTc), Novartis Pharma AG, Basel
15:30 ÷ 16:15 Coffee/Tea break
16:15 ÷ 17:00 Feedback on meeting between EFPSI and EMEA Efficacy Working Party, January 11th, 2005
Kit Roes (vice-president EFSPI), NV Organon, Oss
17:00 Closure followed by an Informal Drink

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