Applied Statistics
Stability Testing
Radisson SAS Royal Hotel, Golden Lane
Dublin 8, Ireland (IE)
xx, Ireland
Stability Testing
Informa Life Sciences
Radisson SAS Royal Hotel, Golden Lane

Schedule of Presentations:

Wednesday, April 1, 2009
08:25:00 Check-In
08:30:00 Registration
09:00:00 Introduction by the Chair
09:10:00 Regulatory perspective on performance of stability programmes Mike Morris
09:50:00 Stability Testing for global markets Manuel Zahn,
10:30:00 Morning coffee
11:00:00 Monitoring stability in line with new requirements for Asean and Anvisa country (zone IV B) Nicoletta Scione
11:40:00 Spotlight session
12:10:00 Maintaining stability during transport and shipment, an Industry perspective Grzegorz Makowski
12:50:00 Lunch
14:00:00 Using the ICH topic Q1D: Bracketing and Matrixing to your advantage
14:40:00 Practical session on Bracketing and Matrixing, including case study and small group discussion Lone Steenholt,
15:30:00 Afternoon refreshments
16:00:00 Save time and money by optimising your container closure system in stability testing Wolfgang Grimm
16:40:00 Industry Perspective: Susan Smith
16:40:00 Management of outsourcing projects
17:20:00 CRO perspective:
17:50:00 Discussion panel:
18:10:00 Closing remarks from the Chair and end of day 1
18:15:00 Anouncements
Thursday, April 2, 2009
09:00:00 Opening remarks by the Chair
09:10:00 Designing stability programmes for early stage development Geoff Carr,
09:50:00 Performance of photostability testing in accordance with the guidelines Usfeya Muazzam
10:30:00 Morning coffee
11:00:00 Implementation of forced degradation studies to predict drug product stability Rok Jurecic
11:40:00 Optimal handling of OOS and OOT results within long term stability studies Stephen Grier
12:20:00 Lunch
13:30:00 Optimising the statistical evaluation of your stability data Joachim Lutz
14:10:00 Experiences with statistical evaluation of stability data Robert-Jan de Brij
14:50:00 Afternoon refreshments
15:20:00 Generics: differences seen in stability programmes Natasa Djordjevic Filijovic
16:00:00 Discussion forum
16:20:00 Closing remarks by the Chair and end of the conference
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