DIA 2017 Annual Meeting

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Developing Pharmacovigilance Policy Based on Impact

Session Chair(s)

Alan Hochberg

Principal Scientific Enablement Director, Scientific Enablement and Processes

Genentech, A Member of the Roche Group, United States

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

Speaker(s)

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

Shelley Gandhi, MSc

NDA Group, United Kingdom

Strategic Advisor, Pharmacovigilance and Drug Safety

Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

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