Back to Agenda
International Regulatory Convergence
Session Chair(s)
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
The objective of the forum is to highlight leadership from international regulatory agencies on the fight against antimicrobial resistance, including efforts such as the Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR), the tripartite EMA-FDA-PDMA meetings, bilateral EMA-FDA initiatives and the cooperation with WHO (including PAHO), OIE and Codex Alimentarius.
We intend to show how international regulatory authorities cooperate to ensure global coordination of research activities, convergence on regulatory requirements for the approval of antibacterial agents, support to discussions on new business models for antibacterial agents, on alternative therapeutics approaches to antibiotics, and on prevention of resistance across regions, including antimicrobial stewardship following the One Health approach.
Learning Objective : Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.
Speaker(s)
Ivo Claassen, PHD, MSC
Deputy Executive Director and Head of Veterinary Medicines Division, European Medicines Agency, Netherlands
Guido Rasi, MD
Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology, Tor Vergata University of Rome, Italy
Tatsuya Kondo, MD, PHD
President, SH Medical Excellence JAPAN, Japan
Pierre Sabourin, MBA
Assistant Deputy Minister, Health Products and Food Branch, Health Canada, Canada
Donald Prater, DVM
Assistant Commissioner for Food Safety Integration, OC, FDA, United States
Have an account?