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Regulatory Submissions, Information, and Document Management Forum

Session 8 Track 4: Using Submission Management to Enable Streamlined Regulatory Planning

    Session Chair(s)
      Michelle L. Charles, MPH

      Michelle L. Charles, MPH

      • Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
      • University of Pennsylvania, Perelman School of Medicine, United States
    This session will focus on how you can work business efficiency and project management into all aspects of regulatory submissions. We will begin with a presentation focused on the implementation of a global submission planning tool to enable portfolio management, then move to a presentation optimizing submission resources, and end with how to efficiently manage a submission lifecycle.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe the benefits of an integrated approach to regulatory submission authorization, planning, and execution
    • Recognize the value of using unified global submission planning process and tools to develop portfolio-level reporting and information to drive strategic decision-making for prioritization, resource management, and to drive planning for manufacturing and sales and marketing divisions
      Laura  Shelley, RPh, PMP

      Enabling Global Regulatory Submission Project and Portfolio Management Via a Unified Submission Planning Toolset

      Laura Shelley, RPh, PMP

      • Regulatory Portfolio and Submission Management, GRACS
      • Merck & Co., United States
      Laurie  Henricks

      Submission Lifecycle Management

      Laurie Henricks

      • Director, Regulatory Submissions Operations
      • Cardinal Health Regulatory Sciences, United States
      Stephanie J Hughes

      Utilizing Submissions Management to Free Up Resources in Regulatory Affairs

      Stephanie J Hughes

      • Regulatory Submissions Management Associate
      • Teva Pharmaceuticals Inc., United States