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Tuesday, June 28 • 4:00pm - 5:15pm
#272: How Can We Build Reliability and Quality When Outsourcing Pharmacovigilance?

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss the concept that there is no agreed upon or standardized approach to outsourcing pharmacovigilance. Other industries use the safety case model so vendors present a common model for sponsors to examine and the latest thinking will be applied to pharmacovigilance outsourcing.

Learning Objectives

Discuss a more standardized approach to outsourcing pharmacovigilance; Identify a common model for pharmacovigilance outsourcing.


Brian David Edwards


Pharmacovigilance Sourcing, Emerging Business Models
Kelly Traverso

Pragmatic Approach to Pharmacovigilance Outsourcing
Lillian M. Kirk, DrSc

avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →

avatar for Lillian Kirk

Lillian Kirk

Director, Global Pharmacovigilance Case Management, Alexion
Lillian is a Doctor of Chiropractic with over 19 years’ healthcare experience, including clinical practice, teaching, drug safety/pharmacovigilance & medical affairs. The last 3 years, she provided safety expertise companywide & for external partners. She has worked to develop valuable... Read More →
avatar for Kelly Traverso

Kelly Traverso

Consulting Specialist Leader, Deloitte
Kelly has over 17 years of industry and consulting experience in Life Sciences. She has significant consulting experience in the areas of Quality, Pharmacovigilance, R&D and Regulatory Affairs. Projects she has led and provided extensive subject matter expertise on include, Process... Read More →

Tuesday June 28, 2016 4:00pm - 5:15pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety/PV, Session