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Translating New Knowledge from Regulatory Science into Postmarketing Safety Practice
Session Chair(s)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER
FDA, United States
This forum will discuss interactions between lessons learned in regulatory science and regulatory activities and the challenges met to translate results into changes of pharmacovigilance practice. This forum will include topics such as Impact, Mini-Sentinel, Protect, public health and regulatory science.
Learning Objective : Discuss how regulatory knowledge is a fast evolving area and how it has a tremendous impact in safety pharmacovigilance; Describe how up to date information about the new regulatory knowledge will benefit the attendee and allow them to plan in advance the required pharmacovigilance practice processes; Identify the benefit of designing a safety process that will be efficient and compliant driven.
Speaker(s)
Systems Pharmacology and Postmarket Safety: Regulatory Perspective
Darrell R. Abernethy, MD, PhD
FDA, United States
Associate Director for Drug Safety, Office of Clinical Pharmacology, CDER
The Clinical Trials Transformation Initiative IND Safety Reporting Advancement Project: Findings and Next Steps
Michael D Jones, MBA
Eli Lilly and Company, United States
Senior Director
Translating New Knowledge from Regulatory Sciences into Postmarketing Safety Practice
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
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