Clinical Development and NDA Submission in Japan

 

Clinical Development and NDA Submission in Japan

Regulatory Courses

Japanese regulations are very different from ours; if you want to know more about the country specific requirements for NDA submissions, you need to understand the Japanese Regulatory Agencies or you need to comprehend the clinical development processes in Japan; this course is yours.

dates
location
language
06 Sep 2012 Brussels English
1 800,00 €
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full description

Changes in the Japanese regulatory environment have had a dramatic impact on global pharmaceutical development strategy. Decreasing costs and overall clinical trial time, coupled with high quality data has made Japan an attractive choice for conducting trials, but navigating the modern regulatory
requirements of this country can be a challenge.
This one day course, presented by experts from the largest and longest running Japan-based regulatory and strategy consultancy, covers all the procedures that need to be followed in order to begin clinical trials in Japan.
The scientific advice meeting with the Pharmaceuticals and Medical Devices Agency (PMDA) and the country-specific requirements for New Drug Application (NDA) submission will be covered as well as the advantages of priority review drugs and the vital points in the regulatory procedures after
submission.

Who should attend?

Personnel from regulatory affairs, clinical development, project management and business development.

Trainers
  • Organisation of Japanese Regulatory Agencies
  • The Scientific Advice Meeting with the PMDA
  • Clinical Development in Japan
  • Requirements for J-NDA submission and Contents of the J-CTD
  • Priority Review Drugs, orphan drugs/non-orphan drugs
  • Procedures of regulatory review process after J-NDA submission
  • Understand the procedures to start a clinical study in Japan
  • Understand scientific advise meeting with the PMDA
  • Understand requirements for NDA submission in Japan