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Bethesda North Marriott Hotel and Conference Center

03 feb 2025 7:45 a.m. - 05 feb 2025 12:45 p.m.

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Early Bird Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Session 6, Track 1: DIA RIM Reference Model V2.0 catches FHIR!

Session Chair(s)

Jennifer  Dames

Jennifer Dames

Director, RA Submission Management

Abbvie, United States

In this session, we will provide an overview of the updates to the RIM Reference Model in 2024. We will discuss physical implementation specifications for data requirements for organizations considering a RIM initiative and explain how to create a physical model to support migration activities between RIM systems and also real time integrations between RIM and other regulatory systems.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Gain understanding of updates to DIA RIM Reference Model (V2.0)
  • Understand use of the model as data requirements specification for an organization considering a RIM initiative and/or a regulatory data hub
  • Explore how the model could be utilized as a data migration map between different RIM systems and/or in an M&A scenario

Speaker(s)

Venkatraman  Balasubramanian, PhD, MBA

Overview and Highlights of RIM Reference Model V2.0

Venkatraman Balasubramanian, PhD, MBA

VB Insights, LLC, United States

Healthcare and Life Sciences Strategic Advisor

John  Jones, MBA

RIM Reference Model V2.0: Deep Dive

John Jones, MBA

EntiTech Solutions, United States

Chief Executive Officer

Vahe  Ghahraman, PhD

Leveraging the RIM Reference Model in a Small Company Setting

Vahe Ghahraman, PhD

Apellis Pharmaceuticals, Inc. , United States

Senior Director, Global Regulatory Operations Head

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