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Wednesday, June 21 • 2:00pm - 3:15pm
#349: Pharmacovigilance 2.0: Redesigning for the Future

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-540-L04-P; CME 1.25; IACET 1.25; RN 1.25

Pharmacovigilance is a highly regulated environment with defined requirements for compliance and quality. The rapidly evolving world of artificial intelligence and machine learning has been applied to many industries with much success. How can these technological advances be applied to pharmacovigilance? Do they have a place in pharmacovigilance? Can they truly deliver the 3 C's: control, consistency, and cost savings? Real world examples will presented where these innovations are already in use, the difficulties encountered, and how organizations are harnessing the art of the possible.

Learning Objectives

Describe available automation and artificial intelligence technologies; Discuss where these innovations are being applied; Describe tools to assess organizational readiness for this major redesign.


Annette S. Williams, MBA, RPh


Pharmacovigilance and the Promise of Artificial Intelligence
Annette S. Williams, MBA, RPh

Information Technology Innovation in R&D: One Company's Journey, So Far
Robert A. Taylor

Unlocking Incredible Value in Safety Databases Together: The Platform Opportunity
Sundeep Surendra Sethi, MD, MBA

Pharmacovigilance Innovation
Glenn Carroll, MBA

avatar for Annette Williams

Annette Williams

Vice President, Lifecycle Safety, QuintilesIMS
With more than 25 yrs of pharmaceutical experience, in both the clinical and commercial sectors, she leads the Pharmacovigilance Services (PV) unit, which encompasses comprehensive global Safety Operations (case processing and regulatory reporting), Project Management, and Safety... Read More →

avatar for Glenn Carroll

Glenn Carroll

Principal, Deloitte, United States
Glenn Carroll is a principal in our life science strategy practice with over 15 years pharmaceutical and biotech experience. Glenn leads Deloitte's US Safety and Medical practices. He has a strong track record in delivering strategic and operational excellence, specifically in the... Read More →
avatar for Sundeep Sethi

Sundeep Sethi

Vice President, AbbVie, Inc.
Dr. Sethi is VP Safety Operations at AbbVie. In 15 years in the pharmaceutical industry he has held roles in clinical development, regulatory affairs, medical affairs, and pharmacovigilance. Prior to industry Dr. Sethi worked at the Boston Consulting Group. His passions are transforming... Read More →
avatar for Robert Taylor

Robert Taylor

Director, Safety Systems Management, Merck & Co., Inc.
Rob Taylor is a director with Merck with over 20 years experience leading Global Regulatory Affairs and Clinical Safety teams and programs. Rob is leading the exploration of innovative, disruptive initiatives to streamline and potentially change the way we use technology to process... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session