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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



[DIAmond Session 1] New Challenges for Innovation - ICMRA Innovation Project -

Session Chair(s)

Rita  Purcell, LLM

Rita Purcell, LLM

Deputy Chief Executive

Health Products Regulatory Authority (HPRA), Ireland

Guido  Rasi, MD

Guido Rasi, MD

Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology

Tor Vergata University of Rome, Italy

The International Coalition of Medicines Regulatory Authorities (ICMRA) is composed of executives from each participating national/regional regulatory agency, and discusses each agency’s experiences as well as strategies for resolving common issues. One of the top strategic priorities of ICMRA is the Innovation Project. This project is composed of three work streams, which aims to 1) investigate and research each agency’s horizon scanning methodology, 2) share and leverage outcomes of horizon scanning, and 3) discuss the latest trends in novel pathways to licensing. In this session, the leads of each work stream will present the latest findings and discusions.


Tatsuya  Kondo, MD, PhD

The Report form WS1; Analysis of Global Best Practice in Horizon Scanning Methodologies

Tatsuya Kondo, MD, PhD

SH Medical Excellence JAPAN, Japan


Agnès  Saint-Raymond, DrMed

The Report from WS2; Leveraging from Outcomes of Horizon Scanning

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

Pierre  Sabourin, MBA

The Report from WS3; Novel Approaches to Licensing

Pierre Sabourin, MBA

Health Canada, Canada

Assistant Deputy Minister, Health Products and Food Branch

Nikolai Constantin Brun, MD

Nikolai Constantin Brun, MD

Danish Medicines Agency, Denmark

Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics

John  Graham, PhD, MBA

John Graham, PhD, MBA

FDA, United States

Director, Office of Research Center for Veterinary Medicine