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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-S6] What Information and Communication Do Patients Want in Clinical Trials? How We Can Provide Them? (Part 2)

Session Chair(s)

Yasuhiro  Fujiwara, MD, PhD

Yasuhiro Fujiwara, MD, PhD

Chief Executive

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Yoshikata  Furuya, MSc

Yoshikata Furuya, MSc

Manager, General Affairs Division

Sankeien Hoshoukai Foundation, Japan

In order to engage patients as a partner in drug development and promote their involvement, it is important to understand patients’ needs in information and communication in clinical trials then provide them to patients. Disclosure of clinical trial information and provision of lay summaries of clinical trial results are beginning to be carried out in Japan. This session aims to understand what information and communication patients are seeking before, during and after clinical trials, and discuss how we should provide them to patients based on the regulations and case studies in Japan and global. In part 2 session, status in EU on patient communication will be stared and all speakers of part 1 and 2 sessions will have a panel discussion.

Speaker(s)

Agnès  Saint-Raymond, DrMed

Efforts and Status in EU on Patient Communication and Information Sharing in Clinical Trials

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

Iris  Loew-Friedrich, DrMed

Industry’s Efforts on Patient Communication and Information Sharing in Clinical Trials in EU

Iris Loew-Friedrich, DrMed

UCB SA, Belgium

Executive Vice President and Chief Medical Officer

Kazuhiko  Mori, PhD, MSc

Kazuhiko Mori, PhD, MSc

Japan Pharmaceutical Manufacturers Association (JPMA), Japan

Senior Managing Director

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