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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 4 - Technology Considerations for Next Generation RIM solutions

Session Chair(s)

Jake  Doran

Jake Doran

Vice President, Digital

Lykos Therapeutics, United States

Technology innovation in the RIM space has not been as transformational over the years as what we have seen in other areas, i.e. Clinical, Safety, etc. Is this paradigm about to change? What is industry doing to address the current needs around information and what are the strategic decisions that come from having a clear vision into RIM data? We will take an in-depth look at the value of regulatory data and how it is now being viewed as a strategic corporate asset. We will then transition in to a discussion around disruptive technologies and how technology has driven the transformation in other verticals and then finally take an in-depth look at the current state of the technology available in the RIM space and evaluate what is needed in order to be successful in the future. Are we on the cusp of the next generation of RIM tools?

Learning Objective : 1. Identify challenges in collecting and managing high-quality regulatory information 2. Compare and contrast with best practices in other verticals such as banking and financial sectors 3. Highlight considerations to treat regulatory information as a corporate asset

Speaker(s)

Venkatraman  Balasubramanian, PhD, MBA

Regulatory Information: (Un)necessary Evil or Corporate Asset?

Venkatraman Balasubramanian, PhD, MBA

VB Insights, LLC, United States

Healthcare and Life Sciences Strategic Advisor

Michael  Sauter

Digital Health Impact on Regulatory and RIM

Michael Sauter

United States

Senior Director, Global Regulatory Operations

John  Jones

Achieving a Future State RIM Solution

John Jones

Independent Contractor, United States

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