Regulatory Submissions, Information, and Document Management Forum

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Session 9 Track 3: How to Utilize Systems and Technology as Document Enablers

Session Chair(s)

Jamie Toth, MS

Global Head, TMF Management & Records, Beigene, United States

This session will focus on utilizing technology within the EDMS space and the importance of applying business process, utilizing system vendors as partners, and having technology be a differentiator and improve interoperability.

Learning Objective :
At the conclusion of this session, participants should be able to:

Understand the importance of establishing business processes to drive EMDS configuration and implementation

Influence adoption of an EDMS through robust training and change management

Apply an infrastructure that supports continuous improvement for EMDS post-implementation

Understand the need for single-sources of truth beyond IDMP and text snippets used for auto-generated documents

Speaker(s)

Cheryl Ressland

Executive Director, Regulatory Operations, Daiichi Sankyo, United States

Successful Business Process Driven EDMS Implementation in Less Than Nine Months

Dalia El-Sherif, DRSC, PHD

Partner, Pyxa Solutions, United States

Speaker

Hans van Bruggen, MSC

Director of Regulatory Affairs, Celegence, United States

Structured Content Management: Auto-Population and Auto-Generation of Documents at Roche

Christina Mantzioros , MS

Clinical Solutions Specialist, Montrium, Inc., Canada

eTMF Interoperability: The Move Towards Content Portability