9th Annual Biomarkers Congress
6th Annual Stability Testing for Pharmaceuticals
Renaissance Penta Vienna Hotel
The Imperial Riding School Vienna Ungargasse 60,
Vienna,, Austria
http://www.informa-ls.com/stability
6th Annual Stability Testing for Pharmaceuticals
Informa Life Sciences
http://www.informa-ls.com/stability
Renaissance Penta Vienna Hotel
The Imperial Riding School Vienna Ungargasse 60,
Vienna
Austria

Schedule of Presentations:

Tuesday, November 25, 2008
08:30:00 Registration
09:00:00 Opening remarks by the Chair
09:10:00 A regulator’s interpretation of the European stability testing guidelines Janneke van Leeuwen
09:50:00 Stability testing in clinical trials Sean M Grimmond
10:30:00 Morning tea and coffee
11:00:00 Spotlight session
11:30:00 Stability testing for biologics and the FDA; a product life-cycle approach
12:00:00 Insight into the WHO guideline on vaccines William M. Egan
12:20:00 Panel discussion: Perspectives, roles and guidelines from the FDA and their future outlook on stability testing
12:40:00 Lunch
14:10:00 Implementing ICH topic Q1D: Bracketing and matrixing for stability testing Lone Steenholt,
14:55:00 Understanding global stability testing requirements Manuel Zahn,
15:35:00 Afternoon refreshments
16:05:00 A global stability strategy post Zone IVb Martin Bushell,
16:45:00 Best practice statistical evaluation of stability data Simona , Bohanec
17:25:00 Management of OOS and OOT results Joseph Kottathu
18:05:00 Closing remarks by the Chair and end of Day 1
Wednesday, November 26, 2008
09:00:00 Opening remarks by the Chair
09:10:00 On-going stability programme: expectations and experiences of a GMP-Inspector Jürgen Mählitz
09:50:00 On-going stability testing: an economical approach Sven Oliver Kruse,
10:30:00 Morning tea and coffee
11:00:00 Conducting forced degradation studies to ensure compliance to the guidelines Geoff Carr,
11:40:00 Predict your stability results through well designed stress tests Maja Tabak-Slo˘si´c
12:20:00 Lunch
13:40:00 Quality by Design approach to stability testing - an opportunity Jon V Beaman
14:20:00 Ensuring in-use testing accurately mimics consumer behaviour Stefan Kaupp,
15:00:00 Afternoon refreshments
15:30:00 Stability testing for generics: Overcoming the challenges Jan Jiskra,
16:10:00 Validation of analytical methods suitable for stability studies Manfred Fischer,
16:50:00 Closing remarks by the Chair and end of conference
4th Annual Pharma R&D Asia Congress
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