3D Tissue Models
Forced Degradation Studies
Hotel Bloom
Belgium, xx
Forced Degradation Studies
Hotel Bloom

Schedule of Presentations:

Tuesday, January 27, 2009
08:30:00 Registration
09:00:00 Welcome and opening comments by the Chairpersons Karen Alsante
09:10:00 Understanding the chemistry behind degradation pathways Karen Alsante
09:50:00 Oxidative Susceptibility Testing: Rapid, Comprehensive Screening Techniques Steve Baertschi
10:30:00 Discussion session: Chemical degradation Karen Alsante
10:50:00 Morning coffee
11:20:00 Design of forced degradation studies for small molecules in drug discovery Philip MacFaul
12:00:00 Approaches for conducting HPLC studies for co-eluting components in forced degradation samples Geoff Carr
12:40:00 Performing photostability testing with Xenon chambers Oliver D. Rahäuser
13:10:00 Lunch
14:30:00 Developing an expert computer system to predict degradation pathways Martin Ott
15:10:00 Non-isothermal stability studies Helmut Reithmeier
15:50:00 Afternoon refreshments
16:20:00 Late stage approach to stress testing and compilation of the Common Technical Dossier (CTD) Stuart Goodall
17:00:00 Discussion session on issues arising from the day with a panel of the days’ speakers
17:20:00 Closing remarks by the Chairperson and end of day 1
Wednesday, January 28, 2009
09:00:00 Opening remarks by the Chairperson Thomas Andersson
09:10:00 Detection, quantification and elucidation of impurities Piet Hoogkamer,
09:50:00 Scientific challenges and regulatory impact of genotoxic impurities Thomas Fürst
10:30:00 Morning refreshments
11:00:00 Forced degradation studies and potential genotoxic impurities assessment Alan McKeown
11:40:00 Discussion on genotoxic impurities with a panel of the mornings’ speakers
12:00:00 Spotlight session
12:30:00 Lunch
13:50:00 Increase the probability of successfully developing a stable dosage form in a timely fashion through appropriate drug excipient compatibility studies Sara Vrielynck
14:30:00 Understanding how APIs and excipients degrade in formulations Thomas Andersson
15:10:00 Afternoon Refreshments
15:40:00 Application of forced degradation data to formulation development Philip Jupp
16:20:00 Working within and complying to global regulatory constraints for small molecules Jessica van Montfoort
17:00:00 Discussion session with a panel of the day’s speakers
17:20:00 Closing remarks by the Chairperson and end of the conference
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