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Session 6B: Tools and Technology Track - A Case Study of Global Regulatory Affairs Information Management (RIM)
Session Chair(s)
Dominique Lagrave, PharmD
Senior Vice President of Regulatory Innovation
Accumulus Synergy, United States
Traditional RIM systems have focused on the relatively narrow focus of regulatory submissions and related tracking activities. The growing number of factors contributing to a demand for more expansive RIM solutions will be discussed.
Speaker(s)
Presenter
Rachel Carle
Genzyme Corporation, United States
Sr. Director, Regulatory Operations
Presenter
Meredith K Sewell
Sarepta Therapeutics, United States
Vice President, Regulatory Operations
Additional FDA Speakers Invited
United States
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