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Wednesday, June 29 • 2:00pm - 3:30pm
#350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort?

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-582-L05-P; CME 1.50; IACET 1.50; RN 1.50

Some health authority regulations require the assessment of all adverse events from solicited programs. This session will present multi-company data and discuss various viewpoints from both industry and health authority representatives.

Learning Objectives

Evaluate the quality of adverse event information from solicited programs for potential safety signals; Assess various program types to develop a pragmatic, risk-based approach for appropriate safety oversight; Recognize how to standardize handling of solicited programs for market authorization holders and health authorities to generate insight into real-life use of marketed drugs and patient perception.


Bruce A. Donzanti, PhD


Industry Survey on Pharmacovigilance Oversight of Solicited Programs
Jamie Portnoff

A Regulatory View of ICSR Reporting Requirements for PSPs
Mick Foy

Pragmatic Compliance: A QPPV View of PSPs
Sue Rees, MS

Organized Data Collection Systems: A Pure Compliance Challenge or More?
Heike Schoepper, MD, MBA

avatar for Bruce Donzanti

Bruce Donzanti

Senior Group Director, Pharmacovigilance Innovation Policy, Genentech, A Member of the Roche Group
Bruce has a PhD in pharmacology with 20+ years experience in the pharma/bio industry, mostly in drug safety but he has also worked in other areas such as pre-clinical research. During the past 5 years, Bruce was Head, Drug Safety at Genentech before transitioning into a new role in... Read More →

avatar for Mick Foy

Mick Foy

Group Manager, Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 9 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is also responsible for two large European projects to improve drug safety... Read More →
avatar for Jamie Portnoff

Jamie Portnoff

Vice President, Foresight Group International
Jamie Portnoff is a Vice President and Global Practice Leader with 15 years of experience in Life Sciences. In the past 10 years Ms. Portnoff has delivered a broad scope of business solutions including multiple PV operational and organizational integrations. Prior to Foresight, Ms... Read More →
avatar for Sue Rees

Sue Rees

EU QPPV, Executive Director, Global Patient Safety, Amgen Ltd
Sue has been in the pharmaceutical industry for over 25 years. Sue joined Amgen in 2013 as EU QPPV, based in Cambridge, UK. Sue is an honorary Fellow of PIPA and sits on the Efpia PV Expert Group. Prior to joining Amgen Sue spent 3 years at Eisai Europe as Head of International PV... Read More →
avatar for Heike Schoepper

Heike Schoepper

Head of Global Drug Safety, Merck KGaA
Heike is a registered physician, practiced in internal medicine at university hospital in Berlin and Erlangen, Germany. She holds specialist registration in internal medicine and diplomas in public health, epidemiology from the University in Heidelberg, Germany and a diploma in tropical... Read More →

Wednesday June 29, 2016 2:00pm - 3:30pm EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety/PV, Session