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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
Senior Director, Regulatory Affairs Operations, 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
Senior Manager, Regulatory Submissions, Allergan, United States
Global RIM & Publishing Alignment After M&A
Ronnie Rajkumar
Senior Manager, Regulatory Submissions, Allergan, United States
Global RIM & Publishing Alignment After M&A
Marina Nisenzon, MS
Regulatory Affairs, Merck, United States
Implementing a Regulatory Archive Management System and Consolidating Multiple Legacy Local Archive Systems
Deborah Lahr
Associate Director, Regulatory Content Information Management, Merck & Co., Inc., United States
Implementing a Regulatory Archive Management System and Consolidating Multiple Legacy Local Archive Systems
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