Back to Agenda
ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science
Session Chair(s)
Sandra Kweder, MD
Principal, Drug and Biological Products , ELIQUENT Life Sciences, 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
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
MHRA Update
Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Policy Update
Health Policy Analyst, Directorate for Employment, Labour and Social Affairs, Organisation For Economic Co-Operation and Development (OECD), France
EMA Update
Head of Therapies for Neurological and Psychiatric Disorders, European Medicines Agency, Netherlands
Have an account?