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Thursday, June 18 • 5:00pm - 6:00pm
#504.1 OD: ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science

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Component Type: Session
Level: Intermediate

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 Objectives

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.


Sandra L. Kweder, MD


FDA Update
Gerald J. Dal Pan, MD, MHS

MHRA Update
June Munro Raine, MD, MSc, FRCP

Policy Update
Cristian A Herrera, MD, MBA, MSc

EMA Update
Pavel Petrov Balabanov, MD, PhD


Pavel Balabanov

Head of Therapies for Neurological and Psychiatric Disorders, European Medicines Agency
I am a clinical neurologist who before joining the EMA worked as a consultant neurologist at the Clinic of Neurology, University Hospital – Plovdiv, Bulgaria. I have a PhD in Neurology and hold a position of senior teaching professor of neurology at the Department of Neurology... Read More →
avatar for Cristian Herrera

Cristian Herrera

Health Policy Analyst, Directorate for Employment, Labour and Social Affairs, Organisation For Economic Co-Operation and Development (OECD)
Cristian A. Herrera is a Chilean medical doctor with an MBA and an MSc in Public Policy. He has worked as a primary care physician and manager. Since 2012, he has been an associate researcher at the Department of Public Health of P. Universidad Católica de Chile. Between early 2014... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for June Raine

June Raine

Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr June Raine is the CEO of the Medicines and Healthcare products Regulatory Agency. Dr Raine trained in general medicine in Oxford after completing a Master’s degree by research in pharmacology. Her interest in drug safety led to a career in medicines regulation from 1985 onwards... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   09: Regulatory, Session