09:00 - 11:00120 mins
Introduction to ICH guidances and revised Validation EMA and FDA guidances
11:00 - 12:0060 mins
Traditional and enhanced (Quality by Design) pharmaceutical development
12:00 - 13:0060 mins
Quality by Design (QbD) concept and approaches
13:00 - 14:0060 mins
14:00 - 15:0060 mins
Risk assessment methodologies and practical considerations
15:00 - 16:0060 mins
Stages in process development
16:00 - 17:0060 mins
Case studies will be discussed throughout the day to reinforce learning objectives
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