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Thursday, September 09, 2010
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PSDM Workshop: Recent draft ICH/ CPMP Guidelines revisited
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| 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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