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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 7: Implementation of QbD

Session Chair(s)

Peter  Richardson, PhD

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)

Sharmista  Chatterjee, PhD

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,

Frank  Montgomery, PhD

QbD Where Next - Industry Experience and Perspective

Frank Montgomery, PhD

AstraZeneca, United Kingdom

Global Head Regulatory CMC, GRAPSQA

Kazumi  Kobayashi, PhD

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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