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)

Successful Business Process Driven EDMS Implementation in Less Than Nine Months

Cheryl Ann Ressland

Daiichi Sankyo, United States

Executive Director, Regulatory Operations

Speaker

Dalia El-Sherif, DrSc, PhD

Pyxa Solutions, United States

Partner

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

Hans van Bruggen, MSc

Qdossier, a Celegence Company, Netherlands

CSO

eTMF Interoperability: The Move Towards Content Portability

Christina Mantzioros , MS

Montrium, Inc., Canada

Clinical Solutions Specialist