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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 8: Track 3: Content Migration and Exchange Standards: Perspectives from the Frontline

Session Chair(s)

Karen  McCarthy Schau

Karen McCarthy Schau

Director, Risk-based Study Management

Vertex Pharmaceuticals, United States

Join battle-scarred experts from Sponsor and CROs who share their migration perils and pitfalls, along with alternatives to achieve migration mastery. The session will feature a panel of migration "veterans" presenting on his/her migration experiences, followed by one overview panel presentation on migration success strategies with interactive panel/audience Q&A. The session ends with an overview and update on TMF RM Exchange Mechanism Standard (EMS).

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify practical strategies to avoid migration project problems
  • Describe organizational processes and governance to ensure integrity, quality, and security in migration of data, documents, and records
  • Explain how the eTMF-EMS standard works and the impact on migration strategies
  • Speaker(s)

    Speaker  Invited

    eTMF-EMS - Towards a First Industry Standard for eTMF

    Speaker Invited

    United States

    Karin  Schneider, MLIS, MS

    Karin Schneider, MLIS, MS

    Johnson & Johnson Innovative Medicines, United States

    Associate Director

    Ken  Keefer, MBA, PMP

    Speaker

    Ken Keefer, MBA, PMP

    Keefer Consulting Inc Visa, United States

    Principle Consultant

    Joanne  Malia, MS, MSc

    Speaker

    Joanne Malia, MS, MSc

    Regeneron Pharmaceuticals, United States

    Director, Development Records Management

    Fran  Ross

    Content Migration: Perspectives from the Frontline

    Fran Ross

    Advanced Clinical, United States

    Practice Director, Trial Master File

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