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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1

第15回DIA日本年会

未曾有の変革の時代、イノベーション創出とグローバルヘルスへの貢献を、どのような連携の下で進めていくか

[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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