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Regulatory Submissions, Information, and Document Management Forum

Session 8 Track 3: Creating and Streamlining Regulatory Dossier Management

    Session Chair(s)
      Cindy  Chiu

      Cindy Chiu

      • Director, Regulatory Affairs Operations and Quality Management
      • Merck & Co., Inc., United States
    This session will provide tried-and-tested methods for creating and streamlining regulatory dossier management. This includes a deep dive into the implementation of a cloud-based EDMS at a small biotech how it established a 'one stop shop' for regulatory content reporting and tracking. Also, learn leading practices for expanding regulatory initiatives across the globe by taking a single-dossier approach to product registrations. This session provides strategies on communication, project management, and content management to expedite your product approval projects across the world.
    Learning Objective : Upon completion of this session, the participant should be able to:
    • Explain how a cloud-based EDMS can keep a company agile as they grow in associate numbers, pipeline, and global presence
    • Plan, organize, and distribute the content of Regulatory Dossiers efficiently across the globe
    • Integrate project management best practices into registration strategy
      Richard F Fredericks, MBA

      Designing and Implementing an Integrated Regulatory Experience

      Richard F Fredericks, MBA

      • Associate Director, Regulatory Systems and Information Management
      • Tesaro, United States
      Alex  Butler, MBA

      Take a Global Approach to Regulatory Dossier Management

      Alex Butler, MBA

      • Product Marketing Manager
      • MasterControl, United States
      Lillian  Erickson


      Lillian Erickson

      • QA/RA Director, Gas Sensing, Analysis & Delivery
      • Maxtec, United States