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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 6 Track 2: The Increasingly Critical Roles of RIM Systems and Their Expanding Number of Use Cases Beyond Regulatory Affairs

Session Chair(s)

Michiel  Stam

Michiel Stam

Management Consultant

MAIN5 Gmbh & Co. Kgaa, Germany

RIM systems play an increasingly critical role in our organizations and their scope and use cases extend further beyond the Regulatory Affairs department. This session will focus on strategies and best practices for redefining and implementing RIM systems within today’s organization to successfully support a wide range of applications.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the increasing importance and roles of RIM systems within organizations
  • Provide solutions to address practical challenges of supporting different use cases for RIM simultaneously
  • Formulate a foundational RIM strategy
  • Speaker(s)

    Michiel  Stam

    Global Use Cases and Practical Challenges of Managing Regulatory Information from a Single Source of Truth

    Michiel Stam

    MAIN5 Gmbh & Co. Kgaa, Germany

    Management Consultant

    Vahe  Ghahraman, PhD

    Foundational RIM Strategy for a Small to Medium-Size Enterprise

    Vahe Ghahraman, PhD

    Apellis Pharmaceuticals, Inc. , United States

    Senior Director, Global Regulatory Operations Head

    Sue  Metz

    Manage Change…Don’t Let Change Manage You

    Sue Metz

    IRISS Forum, United States

    President/CEO

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