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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science

Session Chair(s)

Sandra  Kweder, MD

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)

Gerald  Dal Pan, MD, MHS

FDA Update

Gerald Dal Pan, MD, MHS

FDA, United States

Director, Office of Surveillance and Epidemiology, CDER

June  Raine, MD, MSc, FRCP

MHRA Update

June Raine, MD, MSc, FRCP

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Chief Executive

Cristian A Herrera, MD, MBA, MSc

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

Pavel Petrov Balabanov, MD, PhD

EMA Update

Pavel Petrov Balabanov, MD, PhD

European Medicines Agency, Netherlands

Head of Therapies for Neurological and Psychiatric Disorders

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