戻る Agenda
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:
Speaker(s)
Achieving Regulatory Operational Excellence Through Unified Quality and Regulatory Information Management
Chet Shemanski
Ennov, United States
VP Marketing, North America
Dossier Change Control Management: How Changes can be Managed in Industry
Christina Frey
Merck & Co., Inc., United States
Director, Regulatory Affairs
RIM Innovation Evolution: Past, Present, Future Trending
Steve Gens, MS
Gens & Associates Inc., United States
Managing Partner