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Interpretation of New Pharmacovigilance Regulations: Key Insights
Session Chair(s)
Ajay B. Singh
Team Leader, Safety Evaluation and Risk Management
GlaxoSmithKline, United States
Building on the ongoing collaborative efforts of nineteen sponsor companies, a key workstream has been established on how each is addressing major new pharmacovigilance regulations and guidances. This session will provide feedback on key learnings and best practices. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 9:30-10:30AM in the DIA Community Zone 1, Sails Pavilion.
Learning Objective : Explain some of the challenges associated with major new pharmacovigilance guidelines; Discuss how companies are interpreting and implementing the aforementioned guidelines; Share best practices across the industry and learnings from feedback from regulators.
Speaker(s)
Reference Satety Information: Implementing the Recommendations Noted in the CTFG
Ajay B. Singh
GlaxoSmithKline, United States
Team Leader, Safety Evaluation and Risk Management
Update From MHRA
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
Combination Products: Focus on FDA Guidance on Postmarketing Safety Reporting
Jane Carroll, BSN, MS, RN
Moderna, United States
Vice President, Commercial and Medical Operations