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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.

Speaker(s)

Steve  Gens, MS

Steve Gens, MS

Managing Partner, Gens & Associates, United States

From Compliance Burden to Competitive Advantage: RIM KPIs and Metrics

Bernie  Coney, MA

Bernie Coney, MA

Principal Consultant, NNIT, United States

What is "RIM" Exactly?

Peter  Terbeek, MBA

Peter Terbeek, MBA

Executive Director, Regulatory Data and Document Operations, Astellas Pharmaceuticals, United States

From Entropy to Order: RIM Terminology

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