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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 6 Track 1 - RIM Working Group: Thought Leadership on a Complex Issue

Session Chair(s)

Sheila  Mahoney Jewels, MBA

Sheila Mahoney Jewels, MBA

Drug Development Multi-Functionalist

LifeSciHub , United States

This session will be an introduction to the newly formed RIM Working Group, which seeks to collectively explore emerging disparate RIM issues, such as widely varying terminology, non-harmonized definitions of "Core RIM", and high caliber, realistic metrics.
While not a “reference model” as yet, the RIM Working Group seeks to follow the same methodology so successfully employed by the EDM and TMF Reference Model. The goal is to harmonize across three key areas: Core RIM, terminology, and metrics.


Steve  Gens, MS

From Compliance Burden to Competitive Advantage: RIM KPIs and Metrics

Steve Gens, MS

Gens & Associates Inc., United States

Managing Partner

Bernie  Coney, MA

What is "RIM" Exactly?

Bernie Coney, MA

NNIT, United States

Principal Consultant

Peter  Terbeek, MBA

From Entropy to Order: RIM Terminology

Peter Terbeek, MBA

United States

Senior Director, Regulatory Operations

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