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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.

Chair

Annette S. Williams, MBA, RPh

Speaker

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



Moderators
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 →

Speakers
avatar for Glenn Carroll

Glenn Carroll

Principal, Strategy and Operations, Life Sciences, Deloitte Consulting
Glenn is a Principal in the Life Science practice with over 15 years of Pharmaceutical and Biotechnology consulting experience delivering strategic and operating model engagements. He has significant consulting experience in Compliance, R&D, Medical Affairs and Pharmacovigilance... 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 trans... 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 proce... Read More →
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 →


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