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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
Eliquent Life Sciences, United Kingdom
Partner & PV trainer
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