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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 1&3: The Challenges and Benefits of Consolidating Multiple Legacy RIM Systems from Submission Publishing/Global Regulatory to Archival

Session Chair(s)

Cindy  Chiu

Cindy Chiu

Senior Director, Regulatory Affairs Operations and Quality Management

Merck & Co., Inc., United States

The value of consolidating disparate silo-ed submission management and archive systems into a single centralized process is recognized globally by all biopharma companies. However, organizations are faced with the social and technical challenges alignment often brings. This presentation shares the experience from two different companies with the same goals’ perspectives.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Evaluate current systems and practices to implement improvements
  • Implement a new system within a set timeframe
  • Understand the challenges from a change management perspective alignment can bring to an organization

Speaker(s)

Nicole  Cocuzza, MBA

Global RIM & Publishing Alignment After M&A

Nicole Cocuzza, MBA

Allergan, United States

Senior Manager, Regulatory Submissions

Ronnie  Rajkumar

Global RIM & Publishing Alignment After M&A

Ronnie Rajkumar

Allergan, United States

Senior Manager, Regulatory Submissions

Marina  Nisenzon, MS

Implementing a Regulatory Archive Management System and Consolidating Multiple Legacy Local Archive Systems

Marina Nisenzon, MS

Merck, United States

Regulatory Affairs

Deborah  Lahr

Implementing a Regulatory Archive Management System and Consolidating Multiple Legacy Local Archive Systems

Deborah Lahr

Merck & Co., Inc., United States

Associate Director, Regulatory Content Information Management

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