Pharmacovigilance/Risk Management Training Web Cast

FDA has announced a 6/9-10 Web cast entitled “Pharmacovigilance and Risk Management Conference — New Approaches, Tools, and Technologies.” An agency notice describes the training as being designed to provide participants with a “foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug and biological products.” It will include discussions on regulatory approaches to prevent medication errors, pharmacovigilance, and risk management. Featured topics during the conference include:

• Best Practices in Drug and Biological Product Postmarket Safety Surveillance
• Safety Considerations for Product Design, Container Labels and Carton Labeling to Minimize Medication Errors
• Process for Nonproprietary Name Suffix Review for Biological Products
• FDA’s Sentinel Initiative and Sentinel’s role in safety surveillance
• Overview of the Division of Risk Management and review activities
• Development of Shared System REMS and waivers
• Best practices for developing and reporting surveys for REMS  
• Considerations for REMS Assessments – Planning and Reporting