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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.

Chair

Brian David Edwards

Speaker

Pharmacovigilance Sourcing, Emerging Business Models
Kelly Traverso

Pragmatic Approach to Pharmacovigilance Outsourcing
Lillian M. Kirk, DrSc



Chair
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Regulatory Science Ltd.
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 J&J as a deputy QPPV in 2005. In addition he is Director of ISoP Secretariat Ltd, Treasurer of ISoP and Vice President in the Alliance Clinical Research... Read More →

Speakers
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 partnerships with all safety vendors. Dr. Kirk has worked at Pfizer, Purdue & Bayer in oncology, neurology, musculoskeletal, OTC & dietary supplement areas... Read More →
avatar for Kelly Traverso

Kelly Traverso

Specialist Leader, Deloitte Consulting
Kelly is a leader in Deloitte’s Life Sciences R&D Strategy & Operations practice and has over 13 years of industry experience concentrated in the area of Pharmacovigilance and Regulatory.


Tuesday June 28, 2016 4:00pm - 5:15pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA