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Tuesday, June 28 • 10:30am - 11:45am
#221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-555-L04-P; CME 1.25; IACET 1.25; RN 1.25

The complexity of the regulatory environment is growing rapidly in light of new technologies for disease surveillance, diagnostics, and medication. This session will focus on future knowledge and predictions in intelligence with an impact on the regulatory world.

Learning Objectives

Recognize the complexity of the future regulatory environment in light of new technologies; Identify challenges and opportunities in the field of digital data for disease surveillance, personalized medicines and individual stakeholder engagement through innovative tools; Evaluate future knowledge against new technologies.

Chair

Joseph C. Scheeren, PharmD

Speaker

Current Status of Big Data Use in the Health Care Sector: View from the Market
Luke D. Dunlap, MSc

Big Data Being Part of FDA eHealth Policy: Viewpoint of the Regulator
Robert M. Califf, MD

Challenges of Big Data in the Regulatory Environment from the Legal Point of View
Denise Esposito, JD



Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer Consumer Care AG
Joseph Scheeren, Pharm.D. is Senior Vice President, Head Regulatory Affairs for Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of CIRS, PhRMA and DIA. He is a member of Advisory Boards for CIRS, SAFE-BioPharma, Yale Regulatory Affairs Track, and CoRE Singapore. He is an elected corresponding Member of the Academie Nationale de... Read More →

Speakers
avatar for Robert Califf

Robert Califf

Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.
LD

Luke Dunlap

Senior Principal, Real World Evidence Solutions, IMS Health
avatar for Denise Esposito

Denise Esposito

Partner, Covington & Burling LLP


Tuesday June 28, 2016 10:30am - 11:45am
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA