RISK BENEFIT MANAGEMENT SPECIAL INTEREST GROUP
Head to Head Comparison of EMA to US RBM Guidelines

Comparisons of Food and Drug Administration and European Medicines Agency Risk Management Implementation for Recent Pharmaceutical Approvals: Report of the International Society for Pharmacoeconomic and Outcomes Research Risk Benefit Management Working Group.

The citation for this article is:
Lis Y, Roberts MH, Kamble S, et al. Comparisons of Food and Drug Administration and European Medicines Agency Risk Management Implementation for Recent Pharmaceutical Approvals: Report of the International Society for Pharmacoeconomic and Outcomes Research Risk Benefit Management Working Group. Value Health 2012; 15: 1108-1118

A Comparison of US Food and Drug Administration and European Medicines Agency Regulations for Pharmaceutical Risk Management: Report of the International Society for Pharmacoeconomic and Outcomes Research Risk Management Working Group

The citation for this article is:
Lis Y, Guo JJ, Roberts MH, et al. A Comparison of US Food and Drug Administration and European Medicines Agency Regulations for Pharmaceutical Risk Management: Report of the International Society for Pharmacoeconomic and Outcomes Research Risk Management Working Group  ISPOR CONNECTIONS 2011; 17: 10-13.

Developed by The Risk Benefit Management Special Interest Group

Chair:
Yvonne Lis PhD, Director, Carter Lis , Associates, Ltd., Weybridge, Surrey, UK

Leadership Group:
Jianfei (Jeff) Guo, PhD, RPh, Associate Professor of Pharmacoeconomics & Pharmacoepidemiology, University of Cincinnati Medical Center, College of Pharmacy, Cincinnati, OH, USA
Shital Kamble, PhD, MS, MBA, Biostatistician II/ DCRI Research Fellow, Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Durham, NC, USA
Anthony Lockett, PhD, MD, MBA, Medical Director, MEDQP Ltd., Leeds, West Yorkshire, UK
Dennis W. Raisch, PhD, MS, RPh, Professor, PEPPOR (Pharmacoeconomics, Epidemiology, Public Policy and Outcomes Research), College of Pharmacy, University of New Mexico, Albuquerque, NM, USA
Melissa Roberts, MS, CMA, Research Associate Clinical and Outcomes Research, Lovelace Respiratory Institute, Albuquerque, NM, USA

Activities:
Comparisons of FDA and EMA Risk Management Requirements for Recently Approved Products
November 2010 - ISPOR 13th Annual European Congress Forum Presentation, Prague, Czech Republic


Risk Benefit Management Special Interest Group   |  Special Interest Groups Index