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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

Recent Trend of Pharmaceutical Regulation in Europe

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

Rong  Sun, PhD

Recent Trend of Pharmaceutical Regulation in Americas

Rong Sun, PhD

Health Canada, Canada

Associate Director with the Centre for Evaluation of Radiopharmaceuticals and Bi

Junko  Sato, PhD

Recent Trend of Pharmaceutical Regulation in Asia

Junko Sato, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director

Alison  Cossar

Recent Trend of Pharmaceutical Regulation in Oseania

Alison Cossar

Medsafe, Ministry of Health, NZ, New Zealand

Manager, Product Regulation Branch

John  Graham, PhD, MBA

John Graham, PhD, MBA

FDA, United States

Director, Office of Research Center for Veterinary Medicine

Rita  Purcell, LLM

Rita Purcell, LLM

Health Products Regulatory Authority (HPRA), Ireland

Deputy Chief Executive

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