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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.

Chair

Alan M. Hochberg

Speaker

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



Moderators
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 engin... Read More →

Speakers
avatar for Gerald Dal&nbspPan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
Dr. Dal Pan is the Director of the Office of Surveillance and Epidemiology in FDA’s CDER, where he is responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. He is involved in both t... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley Gandhi brings a wealth of experience in the pharmacovigilance arena after being with the MHRA (UK Regulatory Authority) for 19 years and 2 years with the NDA group working with industry. She has extensive knowledge of all European regulatory processes related to monitorin... Read More →
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 engin... Read More →


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