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Session 7: Implementation of QbD
Session Chair(s)
Peter Richardson
Senior Quality Specialist, European Medicines Agency, Netherlands
Industry and regulators have invested substantial resources in the Quality by Design project over recent years. This session will look at some of the gains that have been made for both small (chemical) and large (biological) molecules in this area and address real benefits versus expectations. The field has matured significantly with the implementation of ICH Q8, 9, 10, and 11 guidelines; however, there still remain opportunities to facilitate implementation. Recent progress in the area will be reviewed, such as outcomes from EMA QbD workshop and other FDA initiatives, with perspectives from both industry and regulators.
Speaker(s)
Sharmista Chatterjee, PhD
Division Director in Division of Pharmaceutical Manufacturing II,, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA, United States
The Present and Future of QbD for New Drugs: An FDA Perspective
Frank Montgomery, PhD
Global Head Regulatory CMC, GRAPSQA, AstraZeneca, United Kingdom
QbD Where Next - Industry Experience and Perspective
Kazumi Kobayashi, PhD
Senior Principal Scientist, Technical Development, Biogen Idec, United States
Targeting “Quick but Decisive” Analytics to Support Advanced Process Controls
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