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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

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Session 9: Track 2: Transforming Regulatory with Digital Technologies

Session Chair(s)

Venkatraman Balasubramanian, PhD, MBA

Healthcare and Life Sciences Strategic Advisor

VB Insights, LLC, United States

This session will explore the use of digital technologies including AI and ML in regulatory, especially in the areas of regulatory operations, submissions management, and archiving, among others. It will cover potential use cases to improve compliance, efficiency and automation, as well as an action plan to implement AI and ML within regulatory.

Learning Objective : Upon completion of this session, the participant should be able to:
Identify digital technologies that are available and potential use cases with regulatory affairs
Review how artificial intelligence and machine learning can complement regulatory management in the future
Create plans for the implementation of AI and ML in regulatory operations, especially around submissions management and archiving

Speaker(s)

Exploring Digital Technology in Regulatory Affairs

Scott Cleve

Daiichi Sankyo, United States

Vice President Regulatory Labeling, Operations and Writing

Introducing AI and Automation with Submission

Brian Burke-Green, MSc

Pfizer, United States

Regulatory Manager

The Compliment of AI within Life Science

Robert Connelly, MBA

Incyte, United States

Senior Director, Global Regulatory Operations

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