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3rd DIA Regulatory Affairs Training Course

 
  May 14, 2010  
     
 
Keio University Faculty fo Pharmacy Shiba-Kyoritsu Campus , Tokyo, Japan
Jun 9 2010 - Mar 23 2011


This is a training course for the development and fostering of people from pharmaceutical companies

and regulatory authorities engaged in drug development. The course is aimed at providing basic

knowledge necessary for a regulatory scientist. It facilitates understanding the process and principle

of a drug development in line with a series of events from developmental planning to application

and review, thus making it possible to apply shared learning to cases in the past. The course consists

of ten separate sessions and each session consists of a lecture, small group discussion, and mock

exercise. So it is also expected that skills for negotiation and debate will be improved

Session Date Theme

1 2010/06/09 1) Introduction

2) Target disease

3) Portfolio management and project management

2 2010/06/30 4) Planning of development strategy

3 2010/07/21 5) Planning for patient enrollment into clinical trial

6) Making clinical trial plan

4 2010/08/25 7) Face-to-face advice (preparation for clinical trial

consultation)

5 2010/10/06 8) Face-to-face advice (mock clinical trial consultation)

6 2010/1 1/17 9) Action after face-to-face advice

7 2010/12/15 10) Co-write a CTD (mainly labelling and clinical part in M2)

8 201 1/01/19 1 1) NDA review

9 201 1/03/02 12) Mock interview

10 201 1/03/23 13) Action after interview

14) Review of the course

Closing ceremony

Event Code:
10350

 
 
Organized by: DIA Japan
Invited Speakers: Call contact
 
Deadline for Abstracts: Call contact
 
Registration:

For further information, contact the

Drug Information Association, LLC

office in Tokyo

by telephone +81-(0)3-5833-8444

by fax +81-(0)3-5820-8448

E-mail: diajapan@diajapan.org
 
   
 
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