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Monday, June 25 • 3:00pm - 4:30pm
#156: International Regulatory Convergence

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-553-L04-P; CME 1.50; IACET 1.50; RN 1.50

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 Objectives

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.

Chair

Agnès Saint-Raymond, MD

Speaker

The Fight Against Antimicrobial Resistance: A One Health Approach
Ivo Claassen, PhD, MSc

Panelist
Guido Rasi, MD

Panelist
Tatsuya Kondo

Panelist
Julio Sánchez Y Tépoz

Panelist
Pierre Sabourin, MBA

Panelist
Donald Prater, DVM



Speakers
avatar for Ivo Claassen

Ivo Claassen

Head of Veterinary Medicines Division, European Medicines Agency (EMA)
Dr Claassen is a biomedical scientist by training and obtained his PhD in Virology and Immunology at the Erasmus University in Rotterdam.He started his career in different positions related to R&D,production,QA/QC and regulatory aspects of human and veterinary medicines.For the past... Read More →
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
DP

Donald Prater

Assistant Commissioner for Food Safety Integration, OC, FDA
Dr. Donald A. Prater is Assistant Commissioner for Food Safety Integration at U.S. FDA. He is the principal spokesperson on behalf of the FVM Program for imports discussions with external stakeholders, including foreign governments, and is responsible for import-related strategic... Read More →
avatar for Guido Rasi

Guido Rasi

Executive Director, European Medicines Agency (EMA)
Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →
avatar for Pierre Sabourin

Pierre Sabourin

Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory... 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 →
JS

Julio Sánchez Y Tépoz

Federal Commissioner, COFEPRIS
JS

Julio Sánchez Y Tépoz

Federal Commissioner, COFEPRIS


Monday June 25, 2018 3:00pm - 4:30pm
Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA