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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 9 Track 1: Shaping and Overseeing Regulatory Strategy, Operations, and Vendor Relationships

Session Chair(s)

Rob  Labriola, MS

Rob Labriola, MS

Exec. Director, Regulatory Operations

Garuda Therapeutics, United States

This session will explore best practices that enable high-quality relationships between clients and vendors in the regulatory submissions space. We will delve into the ever-growing number of acquisitions and mergers/partnerships as it relates to strategy and execution in submissions operations. An examination into successfully shifting from a vendor-based RIM model to an in-house operation will be discussed.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Define and explain operational performance with metrics and KPIs
  • Analyze the scope and appraise the process for execution
  • Identify tools, processes, and personnel necessary for success
  • Employ different governance processes to create and maintain high-quality vendor relationships


Amanda  Lewis

Excellence in Vendor Management

Amanda Lewis

Bristol Myers Squibb, United States

Senior Manager, Regulatory Outsourcing Management

Richard  Fredericks, MBA

Shifting from a vendor-based RIM model to a full-service in-house Function

Richard Fredericks, MBA

Mersana Therapeutics, United States

Senior Director, Regulatory Operations and Technology

Rohan  Mammen, MS

Grappling with Asset Transfers – Regulatory Strategy, Execution, and Considerations

Rohan Mammen, MS

BIOGEN, Canada

Manager Regulatory Submission Planning

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