Regulatory Submissions, Information, and Document Management Forum

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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