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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., 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)
Global RIM & Publishing Alignment After M&A
Nicole Cocuzza, MBA
Allergan, United States
Senior Manager, Regulatory Submissions
Global RIM & Publishing Alignment After M&A
Ronnie Rajkumar
Allergan, United States
Senior Manager, Regulatory Submissions
Implementing a Regulatory Archive Management System and Consolidating Multiple Legacy Local Archive Systems
Marina Nisenzon, MS
Merck, United States
Regulatory Affairs
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