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Session 3B: Tools and Technology Track - RIM System Improvement Life Cycle
Session Chair(s)
Antonietta Falbo, MBA
Director, Regulatory Information Management (RIM) Program Office
Janssen Pharmaceuticals, Inc., United States
Continuing to explore the difficulties in building and maintaining a robust RIM system, this session will present the results of a year-long project that focused on RAPID (Regulatory Affairs Product Information Database). Attendees will gain a deeper understand of the necessity of data integrity/quality, data monitoring and importance of defining discrete data entry and ownership roles as they relate to either implementing a new RIM System or updating an existing RIM program.
Speaker(s)
The Rumba RIM System: (RAPID Reboot Part Deux)
Meredith K Sewell
Sarepta Therapeutics, United States
Vice President, Regulatory Operations
RIM Evolution and Future Vision
John Kiser, MSc
Kiser Regulatory Services, United States
Principal
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