Tuesday, June 26 • 8:00am - 9:15am
#210: Artificial Intelligence: The Future of Regulatory Affairs

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-18-563-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on the various aspects of artificial intelligence (AI) currently incorporated in regulatory processes as well a futuristic look at what it can do for the RA function. Case studies and lessons learned on AI pilots within the biopharma and medical device industry will be highlighted as well as FDA's perspective on the future of AI.

Learning Objectives

Identify obstacles in developing an artificial intelligence pilot for regulatory decision making; Discuss lessons learned on a large pharma's groundbreaking artificial intelligence pilot; Analyze the integration of artificial intelligence into regulatory processes including information management.


Linda Bowen


Regulatory 2.0: The Future of Regulatory Affairs and Advanced Technologies
Oliver Steck

Exploring New Ways of Working Using Artificial Intelligence: Proof of Concept Pilot
Dany De Grave

FDA Update
Bakul Patel, MBA, MS

avatar for Linda Bowen

Linda Bowen

Head of Regulatory Policy and Intelligence, Seattle Genetics
Linda has 35 years experience in the BioPharma Industry, of which 25 years were spent in regulatory affairs. She consults on regulatory policy & intelligence issues and is an Associate Professor in the Temple University RAQA Program. She was previously Head of US Regulatory Policy... Read More →
avatar for Dany De Grave

Dany De Grave

R&D Scientific Digital Innovation, Sanofi
Dany is an engineer trained in biology with 20+ years of industry experience at GSK and Sanofi Pasteur. In various positions he supported R&D, clinical, manufacturing and global regulatory submissions. He currently leads the implementation of various cognitive and other innovative... Read More →
avatar for Bakul Patel

Bakul Patel

Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical... Read More →
avatar for Oliver Steck

Oliver Steck

Principal, Deloitte & Touche LLP
Oliver Steck is a Principal in Deloitte & Touche’s Regulatory & Operational Risk Advisory practice. He has over 20 years experience as a management consultant in the life science industry and helped global clients to optimize their organizations and processes in respect of regulatory... Read More →

Tuesday June 26, 2018 8:00am - 9:15am
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA