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Tokyo Big Sight

2018 年 11 月 11 日 9:30 上午 - 2018 年 11 月 13 日 5:40 下午

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

15th DIA Japan Annual Meeting 2018

Innovative technologies such as AI, big data/genomics, and cell/gene therapies are poised to transform healthcare product development across the globe – join us to discuss these topics.

[V1-S2] Recent Trend of Pharmaceutical Regulation in the World

Session Chair(s)

Guido  Rasi, MD

Guido Rasi, MD

Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology, Tor Vergata University of Rome, Italy

Jens Piero   Quartarolo, MD, MBA, MSC

Jens Piero Quartarolo, MD, MBA, MSC

Director of Division for Pharmacovigilance & Medical Devices, Danish Medicines Agency, Denmark

To respond to issues such as innovative technologies, globalization, and the increased awareness about drug safety among the general public, regulators around the world are introducing or revising existing regulation/legislations. In this session, executives from leading regulatory agencies will introduce the latest regulatory trends, as well as cooperation among agencies (e.g. ICH) and other topics.

Speaker(s)

Agnès  Saint-Raymond, DrMed

Agnès Saint-Raymond, DrMed

Head of Division International Affairs, European Medicines Agency, Netherlands

Recent Trend of Pharmaceutical Regulation in Europe

Rong  Sun, PHD

Rong Sun, PHD

Associate Director with the Centre for Evaluation of Radiopharmaceuticals and Bi, Health Canada, Canada

Recent Trend of Pharmaceutical Regulation in Americas

Junko  Sato, PHD

Junko Sato, PHD

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Recent Trend of Pharmaceutical Regulation in Asia

Alison  Cossar

Alison Cossar

Manager, Product Regulation Branch, Medsafe, Ministry of Health, NZ, New Zealand

Recent Trend of Pharmaceutical Regulation in Oseania

John  Graham, PHD, MBA

John Graham, PHD, MBA

Director, Office of Research Center for Veterinary Medicine, FDA, United States

Rita  Purcell, LLM

Rita Purcell, LLM

Deputy Chief Executive, Health Products Regulatory Authority (HPRA), Ireland

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