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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 & Orphan Disease Center
      • University of Pennsylvania, Perelman School of Medicine, United States
    Session 8 Track 4: Using Submission Management to Enable Streamlined Regulatory Planning
    Speaker(s)
      Matthew  Pazdernik, MBA

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

      Matthew Pazdernik, MBA

      • Director, Regulatory Submission Planning and Portfolio Management
      • Merck & Co., Inc., 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

      • Publishing Associate
      • Teva Pharmaceuticals Inc., United States