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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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