The Regulatory Affairs Environment in Japan

Understand how to successfully navigate the Japanese health authorities and bring pharmaceutical products onto the Japanese market.

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3 days course

English

17.650,- DKK ex VAT
(app. 2.373,- EUR ex VAT)
20% discount for public institutions

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Module 4

Summary

This course will provide you with a thorough overview and in-depth case studies on how to successfully navigate the Japanese health authorities and bring pharmaceutical products onto the Japanese market. You will become familiar with the contents of drug dossiers, and the Japanese regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). We will discuss the regulatory procedures throughout the drug development phases and how to successfully consult with PMDA, e.g., in the clinical trial notification phase.

You will get the latest trends in Japanese pharmaceutical regulations and procedures. You will receive lectures from senior Japanese regulatory professionals from industry, CROs and authorities.


Keywords

  • Japanese pharmaceutical regulation
  • Japanese regulatory authorities
  • PMDA
  • Orphan Drug Designation (ODD) in Japan
  • Clinical trial notification, clinical studies and Good Clinical Practice (GCP) in Japan
  • Japanese new drug application
  • Chemical pharmaceutical documentation requirements (CMC)
  • Non-clinical and clinical documentation and requirements
  • Regulations for biologics and biotechnology products
  • Generic drug regulation in Japan
  • Pharmacovigilance
  • National Health Insurance (NHI) pricing
  • Patent and regulatory data protection

What you will learn

  1. To understand the Japanese drug development and post-approval framework and regulatory procedure
  2. The do’s and don’ts of constructive interactions with Japanese colleagues and officials
  3. How to successfully navigate the PMDA consultations
  4. How to play an important role in any project team working on obtaining a marketing authorization in Japan

What your company will get

  1. An employee who understands the Japanese drug development, post-approval framework and regulatory procedures
  2. A regulatory professional who can make recommendations on how to achieve project goals in the shortest possible development time
  3. A regulatory professional who is able to successfully navigate the PMDA consultations
  4. A regulatory professional who can play an important strategic role in project teams working on obtaining a marketing authorization in Japan

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.com. Read our cancellation policy.

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This course is a part of this programme

Regulatory Affairs Diploma

Theoretical and practical aspects ... Read more

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

Send an email

 

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