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Lunch & Learn On-Demand: DA Spotlight - Top 10 Lessons Learned on Regulatory Science from the Opioid Epidemic
Session Chair(s)
Sandra Kweder, MD
Principal, Drug and Biological Products
Greenleaf Health/Elilquent, United States
FDA has several decades of experience and learnings in facing an opioid crisis of enormous proportions. Although only one participant in the battle to turn the tide of morbidity and mortality, the Agency has been deeply engaged in ascertaining how to best use regulatory science to do so, and particularly how to scientifically gauge the impact of regulatory interventions and policy. Traditional pharmacoepidemiology served as a starting point, but FDA has had to adapt and identify new sources of data and methods of analysis to fully contemplate the epidemic and its roots, activities essential to ending it. Dr. Dal Pan has led the Office of Surveillance and Epidemiology in these activities from the beginning, and will share its top lessons, some of which have turned traditional pharmacovigilance and epidemiology on its head. Panelists who represent European organizations who are examining the extent and impact of opioid addiction in their own regions.
Speaker(s)
Panelist
June Raine, MD, MSc, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Executive
Panelist
Jordi Llinares Garcia, MS
European Medicines Agency, Netherlands
Head of Research and Innovation
Panelist
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Panelist
Cristian A Herrera, MD, MBA, MSc
Organisation For Economic Co-Operation and Development (OECD), France
Health Policy Analyst, Directorate for Employment, Labour and Social Affairs
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