Marketplace Donate Now Become a Member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

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.

Back to Agendas

[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)

Fumiaki Kobayashi, PhD

President, CTD inc., Japan

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

Kazuishi Sekino, MS

Coordination Director, Pharmaceuticals and Medical Devices Agency, Japan

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

Shinichiro Takeuchi, MS

Associate Director IDV and CNS APRA, Janssen Pharm KK Japan, Japan

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

Have an account?