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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Joel Finkle
Associate Director, Regulatory Information Management at BeiGene, Ltd
Speaker

Profile

Joel Finkle has just retired as Associate Director, Regulatory Information Management at BeiGene, after a long career on both the Pharma and Vendor sides of the business. He has been a leader in the rise of RIM systems, and the development of the RPS standard being used for eCTD 4.0. He first became involved in RIM after regulatory came down to the IT group and asked if it was possible to send all the minicomputer-based clinical study reports to the FDA reviewer in WordPerfect format – and didn’t say “no.” He still participates in IRISS and DIA forums on RIM and IDMP.

Agenda Sessions

  • Case Study: The Five Stages of Grief over Changing RIM Processes

    09:40