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Tuesday, June 26 • 10:30am - 11:45am
#226: Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

Regulatory agencies have conducted real-world studies of postmarketing safety concerns to inform their regulatory decision-making and explored safety surveillance methods using real-world data. This session will discuss the approach of the FDA, EMA, Health Canada, and PMDA, the challenges faced in exploring new methods and designing and conducting these studies, and future areas of research, including opportunities for international collaborative research.

Learning Objectives

Describe how regulatory agencies have used real-world data for safety surveillance and studies of post-marketing safety concerns; Discuss future areas of research by regulatory agencies using real-world data, including opportunities for international collaborative research.

Chair

Michael D. Blum

Speaker

Regulator’s Utilization of Real-World Data in Pharmacovigilance Activities
Yoshiaki Uyama, PhD

FDA's Sentinel Program
Michael D. Nguyen, MD

EMA Perspective
Agnès Saint-Raymond, MD

Improving the Use of Real World Evidence in the Regulatory Environment: Where Are We Heading in Canada?
Rhonda Kropp, BSN, MPH


Speakers
avatar for Michael Blum

Michael Blum

Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA
Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →
RK

Rhonda Kropp

Director General, Marketed Health Products Division, Health Canada
Rhonda Kropp is currently the Director General for the Marketed Health Products Directorate in the Health Products and Food Branch of Health Canada. She is responsible for the oversight of the vigilance of marketed health products in Canada, including ensuring Canadians and health... Read More →
MN

Michael Nguyen

FDA Sentinel Program Lead, FDA
Michael D. Nguyen, MD is the FDA Sentinel Program Lead and Deputy Director of the Regulatory Science Staff in the Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research (CDER). He oversees the day-to-day management of the Sentinel Program for the Agency... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →

Tuesday June 26, 2018 10:30am - 11:45am
Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session