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Tokyo Big Sight

Nov 15, 2015 9:30 AM - Nov 17, 2015 5:45 PM

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

12th Annual Meeting DIA Japan 2015

The registrants will have access to presentation PDFs through Tuesday, May 17, 2016.

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[V5-S3] Fostering Further Collaboration between PMDA, Company and academia with Efficient “Project Management” in Drug Development

Session Chair(s)

Atsushi Tsukamoto, PhD, MSc

Atsushi Tsukamoto, PhD, MSc

Head is Therapeutic Area Strategies

Daiichi Sankyo, United States

Due to enormous efforts made by both regulatory agencies and pharmaceutical companies, various outcomes, such as shortened review periods, have been achieved. However, new challenges, such as the advancement of technologies and drug development have continued to be challenging. Under this environment, for increased high quality and short turn-around review, what can regulatory agencies and pharmaceutical companies do beyond what we have achieved? In this session, participants will learn the efforts under this challenging situation made by the regulatory agency and companies, and discuss and identify what we can do with further collaboration between the two, considering the fact that we share the common goal (i.e. patient treatment), with the project management framework.

Speaker(s)

The Current Status and Plan of Preparatory Steps for Clinical Trials in Academia

Fumiaki Kobayashi, PhD

CTD inc., Japan

President

Fostering Further Collaboration between PMDA and Applicants with Efficient “Project Management” in Drug Development

Kazuishi Sekino, MS

Pharmaceuticals and Medical Devices Agency, Japan

Director of MID-NET operation and management, Office of Medical Informatics and

Fostering Further Collaboration between PMDA, Company and academia with Efficient “Project Management” in Drug Development

Shinichiro Takeuchi, MS

Janssen Pharm KK Japan, Japan

Associate Director IDV and CNS APRA

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