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Session 5 Track 3: Organization Culture Consideration When Adopting Submission & Document Management Systems
Session Chair(s)
Daniel Orfe, MS
President and CEO
Regulatory eSubmissions, LLC, United States
Learning Objective : Describe a proven solution for optimizing regulatory information management to serve multiple purposes, including regulatory and scientific needs. Discuss controversy and best practices.
Speaker(s)
Expanding the Use of a Regulatory Submission Management System for Nonclinical Records Management
Cindy Chiu
Merck & Co., Inc., United States
Senior Director, Regulatory Affairs Operations and Quality Management
Holistic Regulatory Information, Document and Process Management Solution: How to Get There
Agnieszka Wanat
Valeant, Poland
Regulatory Affairs Director EMEA ICN Products
Holistic Regulatory Information, Document and Process Management Solution: How to Get There
Romuald Braun, MS, MSc, RAC
Uanotau Gmbh, Switzerland
Managing Director
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