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Session 7B: Tools and Technology Track - Quality Benefits for Regulatory Information Management
Session Chair(s)
Sarah Powell, RAC
President
Powell Regulatory Services, United States
One of the most important and yet difficult enterprise processes to manage, is the release of commercial drug product into global markets. From a RIM perspective, this process involves the regulatory assessment of changes, registration management, submissions management, product information management and label management; and touches most regulatory functional areas. This session will focus on the prevention of product recall and quality data.
Speaker(s)
Linking Regulatory Affairs to the Supply Chain to Ensure Compliant Product Release
Kristofer Spahr
Daiichi Sankyo, Inc., United States
Director, Regulatory Information Management
Casey Overman
Biogen Idec, United States
Manager, IT
Nicholas Walzer
Biogen Idec , United States
Director Regulatory Business Operation
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