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Session 8 Track 4: Using Submission Management to Enable Streamlined Regulatory Planning
Session Chair(s)
Michelle L. Charles, MPH
Director, Regulatory Affairs, Gene Therapy Program
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
Speaker(s)
Enabling Global Regulatory Submission Project and Portfolio Management Via a Unified Submission Planning Toolset
Laura Shelley, RPh, PMP
Merck & Co., Inc, United States
Director
Submission Lifecycle Management
Laurie Henricks
Arena Pharmaceuticals, Inc., United States
Sr Director, Regulatory Operations
Utilizing Submissions Management to Free Up Resources in Regulatory Affairs
Stephanie J Hughes
Teva Pharmaceuticals Inc., United States
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