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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 8 Track 3: Acquiring the Knowledge to Survive a Merger - Pregame and Post-game

Session Chair(s)

Divya  Gangaramani, PhD, RAC

Divya Gangaramani, PhD, RAC

Senior Regulatory Specialist

VIR Biotech, United States

The acquisition of one large organization by another can bring unique challenges when both come with their own mature fully compliant regulatory process documentation. This session led by Rich Fredericks, Head of Regulatory Operations and Technology, will touch on many of the steps involved leading up to and during an acquisition from a RIM System Administrator perspective as well as hear from a sponsor with a rich history in the process. The session will cover how a RIM team can ‘future ready’ their system and process to ensure any future acquisition/merger activities run as simple as possible. Often processes are common to both organizations, but there are always wild cards which are discovered and must be addressed. Betsy Fallen, Regulatory Consultant, will share details of the project planning and execution and how the wild cards were managed. Best Practices and considerations which may apply to mergers as well as any large-scale documentation renovation will be shared.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Apply actionable steps to ensure RIM systems and process are ‘future ready’ from an acquisition/merger
  • Recognize the opportunity for compliance and efficiency in a merger situation
  • Explain the challenges of global process integration

Speaker(s)

Richard  Fredericks, MBA

So You've Been Acquired - Now What? Navigating an Acquisition From a RIM Perspective

Richard Fredericks, MBA

Mersana Therapeutics, United States

Senior Director, Regulatory Operations and Technology

Betsy  Fallen, RN

Merger Acquisition - Global Process Documentation Integration: Playing the Long Game

Betsy Fallen, RN

BAFallen Consulting LLC, United States

Consultant

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