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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 5B: Risk-Based Review

Session Chair(s)

Nirdosh  Jagota, PhD

Nirdosh Jagota, PhD

Managing Partner

GRQ Biotech Advisors LLC, United States

Patient confidence in the quality of a product relies on regulatory approval of a product registration, which in turn relies on a company’s effective demonstration and conveyance of control of the quality attributes of that product. Benefits of a product with respect to patient needs have to be appropriately balanced with management of risks and uncertainty. This session will focus on how quality attributes can be conveyed in a product registration to effectively demonstrate how quality attributes are controlled and managed and can be reviewed to provide confidence in the quality of a product.

Speaker(s)

Roger  Nosal, PhD

Confidence in Quality: A Proposal to Unify Approaches to Risk-based Regulatory Review

Roger Nosal, PhD

Pfizer Inc, United States

Vice President, Head of Global CMC

Diane J. Zezza

Presentation Title - TBD

Diane J. Zezza

Novartis Pharmaceuticals Corporation, United States

Vice President and Global Head, Regulatory CMC

Sarah  Pope Miksinski, PhD

Integrated Quality Assessment: The How and What of One Quality Voice

Sarah Pope Miksinski, PhD

Gilead Sciences, United States

Executive Director, CMC Regulatory Affairs

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