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ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science
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.
Learning Objective : Describe the pathways to abuse/misuse of prescription opioids and related adverse outcomes; Describe the data resources for descriptive epidemiology and abuse signal detection; Describe regulatory and policy interventions used to combat the opioid epidemic.
Speaker(s)
FDA Update
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
MHRA Update
June Raine, MD, MSc, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Executive
Policy Update
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
EMA Update
Pavel Petrov Balabanov, MD, PhD
European Medicines Agency, Netherlands
Head of Therapies for Neurological and Psychiatric Disorders
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