Regulatory Submissions, Information, and Document Management Forum

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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

Director Regulatory Information Management

Qdossier - A Celegence Company, United Kingdom

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)

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

Michiel Stam

Qdossier - A Celegence Company, United Kingdom

Director Regulatory Information Management

Foundational RIM Strategy for a Small to Medium-Size Enterprise

Vahe Ghahraman, PhD

Apellis Pharmaceuticals, Inc. , United States

Senior Director, Global Regulatory Operations Head

Manage Change…Don’t Let Change Manage You

Sue Metz

IRISS Forum, United States

President/CEO

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

Speaker(s)

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

Foundational RIM Strategy for a Small to Medium-Size Enterprise

Manage Change…Don’t Let Change Manage You

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