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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)
The Fight Against Antimicrobial Resistance: A One Health Approach
Ivo Claassen, PhD, MSc
European Medicines Agency, Netherlands
Deputy Executive Director and Head of Veterinary Medicines Division
Panelist
Guido Rasi, MD
Tor Vergata University of Rome, Italy
Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology
Panelist
Tatsuya Kondo, MD, PhD
SH Medical Excellence JAPAN, Japan
President
Panelist
Pierre Sabourin, MBA
Health Canada, Canada
Assistant Deputy Minister, Health Products and Food Branch
Panelist
Donald Prater, DVM
FDA, United States
Assistant Commissioner for Food Safety Integration, OC
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