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Tuesday, June 20 • 4:00pm - 5:15pm
#280: Developing Pharmacovigilance Policy Based on Impact

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

A trend is emerging to consider that pharmacovigilance regulations need to be justified in terms of their impact on patient safety, rather than simply being reactions to past concerns. If this idea catches on, it has huge implications for industry and regulators. This session will explore the implications of justifying pharmacovigilance regulations based on their impact on patient safety.

Learning Objectives

Describe the implications of justifying pharmacovigilance regulations based on their impact on patient safety.


Alan M. Hochberg


Future Regulatory Goals of the Periodic Benefit-Risk Evaluation Reports (PBRER ): Are They Being Achieved?
Shelley Gandhi, MS

Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions
Gerald J. Dal Pan

avatar for Alan Hochberg

Alan Hochberg

Scientific Enablement Leader, F. Hoffmann-La Roche Ltd.
Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engineering... Read More →

avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session