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Bethesda North Marriott Hotel and Conference Center

05 feb 2018 7:00 a.m. - 07 feb 2018 3:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

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

Session Chair(s)

Jamie  Toth, MS

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 Ann Ressland

    Successful Business Process Driven EDMS Implementation in Less Than Nine Months

    Cheryl Ann Ressland

    Daiichi Sankyo, United States

    Executive Director, Regulatory Operations

    Dalia  El-Sherif, DrSc, PhD

    Speaker

    Dalia El-Sherif, DrSc, PhD

    Pyxa Solutions, United States

    Partner

    Hans  van Bruggen, MSc

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

    Hans van Bruggen, MSc

    Qdossier, a Celegence Company, Netherlands

    CSO

    Christina  Mantzioros , MS

    eTMF Interoperability: The Move Towards Content Portability

    Christina Mantzioros , MS

    Montrium, Inc., Canada

    Clinical Solutions Specialist

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