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CMC Strategy Forum Summer 2020
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CASSS 2020 COVID-19 Action Plan

Updated March 20, 2020
CASSS leadership continues to monitor the ongoing impact of the COVID-19 (also known as coronavirus) outbreak for our attendees and program partners. We are following the recommendations from the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), and will comply with any policies or restrictions issued by local government and city officials. This event is proceeding as planned. We will update the status of this meeting regularly.

FORUM CO-CHAIRS:

Nina Cauchon, Amgen Inc.
Michael Kennedy, CBER, FDA
Carmilia Ramirez-Jiménez, Ajinomoto Bio-Pharma Services
Ramesh Potla, CDER, FDA

SCIENTIFIC ORGANIZING COMMITTEE:

Lucy Chang, Merck & Co., Inc.
Bharat Dixit, ClearB Therapeutics
Narasaiah Dontha, Celgene Corporation, A Bristol-Myers Squibb Company
Michelle Lytle, Eli Lilly and Company
Polly Mak, Genentech, a Member of the Roche Group
David Robbins, AstraZeneca
Karen Rowlandson, Health Canada
Jason Starkey, Pfizer, Inc.
Cecilia Tami, CDER, FDA

The purpose of this Forum is to understand the "acceptable" approaches to Phase-appropriate GMS and what would be the minimal requirements for Phase I vs. Phase II vs. Phase III GMPs. Topics will include: evolution of Quality Systems, raw materials, testing, equipment, software and production qualification vs. validation. 

      



 

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