Regulatory Submissions, Information, and Document Management Forum

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Session 8: Track 1: The Challenges of Change Management and how will RIM Systems Improve Our Understanding?

Session Chair(s)

Sarah Powell, RAC

President

Powell Regulatory Services, United States

This session will examine the challenges associated with dossier change management and review what one organization has done to help address their compliance concerns. The session will also review the findings from 2018 Regulatory Information Management Survey and how industry is looking to maximize value from technology and process improvement initiatives.

Learning Objective : At the conclusion of this session, participants should be able to:
Identify the processes, systems, and data required to manage variation change controls
Recognize the change history of regulatory content
Discuss the latest industry benchmarks of RIM status and investment priorities for 2018-2020

Speaker(s)

Achieving Regulatory Operational Excellence Through Unified Quality and Regulatory Information Management

Chester Shemanski

Ennov, United States

VP Marketing, North America

Dossier Change Control Management: How Changes can be Managed in Industry

Christina Frey

Merck, United States

Director, Regulatory Affairs

RIM Innovation Evolution: Past, Present, Future Trending

Steve Gens, MS

Gens & Associates Inc., United States

Managing Partner