戻る Agendas
INTERNATIONAL COLLABORATIONS IN PHARMACOVIGILANCE: COMMON OBJECTIVES, COMMON CHALLENGES
Session Chair(s)
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force
European Medicines Agency, Netherlands
Pharmacovigilance is a global enterprise and regulatory science is constantly evolving globally to meet new scientific challenges, particularly those with common objectives. As a result, a patchwork of agreements amongst regulatory authorities has evolved that permit confidential data exchange across jurisdiction and the ability to share perspectives on common objectives and challenges. This session will cover current collaboration between EMA and FDA in pharmacovigilance. Focus will be on drug-specific scientific evaluations, new pharmacovigilance tools, and how regulators address common challenges in the context of legislative constraints.
Speaker(s)
Panel Discussion
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
Panel Discussion
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Panel Discussion
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety