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Workshop II: Microbial In-Use Studies and Closed System Transfer Devices
Date
January 22, 2024
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Session Speakers:
In-Use Studies Microbial Challenge Studies: Cross-Industry Efforts to Harmonize Strategies in Collaboration with Health Authorities
J. Paul Kirwan, Amgen Inc.
Pharmaceutical Industry Perspective on Closed System Transfer Devices (CSTDs): Balancing Overfill, Evaluating, Communicating
Christian Lehermayr, Novartis Pharma AG
Additional Panelists:
Virginia Carroll, CDER, FDA
Nicholas Clark, Amgen Inc.
John Metcalfe, CDER, FDA
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