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Session 7: Implementation of QbD
Session Chair(s)
Peter Richardson, PhD
Head of Quality, Specialised Scientific Disciplines Department
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)
The Present and Future of QbD for New Drugs: An FDA Perspective
Sharmista Chatterjee, PhD
Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA, United States
Division Director in Division of Pharmaceutical Manufacturing II,
QbD Where Next - Industry Experience and Perspective
Frank Montgomery, PhD
AstraZeneca, United Kingdom
Global Head Regulatory CMC, GRAPSQA
Targeting “Quick but Decisive” Analytics to Support Advanced Process Controls
Kazumi Kobayashi, PhD
Biogen Idec, United States
Senior Principal Scientist, Technical Development
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