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Bethesda North Marriott Hotel and Conference Center

2023 年 02 月 13 日 11:30 上午 - 2023 年 02 月 15 日 2:15 下午

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

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 1: New Developments in RIM Reference Model

Session Chair(s)

Vahe  Ghahraman, PhD

Vahe Ghahraman, PhD

Senior Director, Global Regulatory Operations Head

Apellis Pharmaceuticals, Inc. , United States

DIA RIM-WG sub team on RIM Reference Model has been working on establishing a process-centric reference model for quite some time. In this session, the team will present a simpler (object-centric) version of the model. The primary objective of the latest update is to make the model easy to understand, adopt and implement by sponsors, vendors, and system integrators alike. A sponsor will also provide updates on ongoing work related to their product hub use case/application, leveraging elements of the RIM Reference Model. We will also discuss a case study of where the RIM reference model is aligning and helping to shape the creation of a large initiative to share RIM data not only within regulatory but to other departments as well. The case study will discuss elements such as data security, governance, quality, and self-service reporting. Updates on other related activities including RIM whitepaper (V3) and collaboration with other organizations and initiatives (Pistoia & Accumulus) will also be provided.

Learning Objective :
  • Understand updates to the RIM Reference Model
  • Make aware of new content in V 3.0 of RIM Whitepaper
  • Application of the RIM Reference model to create an integrated view of product data
  • Understand how the RIM reference model can be put to practical use for organizational data sharing and reporting

Speaker(s)

Venkatraman  Balasubramanian, PhD, MBA

Progress Report on RIM Reference Model and Applications

Venkatraman Balasubramanian, PhD, MBA

Orion Innovation, United States

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences

Donald  Palmer, MA

Speaker

Donald Palmer, MA

United States

Consultant

John  Jones, MBA

Speaker

John Jones, MBA

EntiTech Solutions, United States

Chief Executive Officer

Donna  Yosua

Speaker

Donna Yosua

Merck & Co., Inc, United States

Director, InforMaster Data Management & Data Governance

Patterson  Shafer

Speaker

Patterson Shafer

FTI Consulting, Inc., United States

Managing Director

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