Technology-transfer 32: Introducing Pharmaceuticals and Medical Devices to Japan

28-02-20 | 10:00 h - 11:00 h

With its large aging population, Japan is one of the world’s largest markets for health care products. Any pharmaceutical or medical device sold in Japan must be approved by the PMDA, a Japanese national regulatory agency similar to the US FDA. We will discuss foreign entry into this market in Japan and practical considerations for dealing with the PMDA with Ariel Weber, who served as a full-time staff member for three years at the PMDA.

Registration deadline: 27/02/2020

Topics learned during this webinar?

Why should a non-Japanese pharmaceutical or medical device producer consider entering the Japanese market and what would be the actual process of interacting with the regulator (PMDA)?

  • Summary of the Japanese market for health care products
  • Preparing for submission to the PMDA
  • Communicating with the PMDA
  • Formal and informal consultations with PMDA
  • Do’s and don’t’s
  • Takeaways

Programme:

  • Introduction
  • Expert's presentation
  • Q&A Session
  • Conclusion

Speakers:  Ariel Weber was the PMDA’s first non-Japanese staff member and served in multiple roles, primarily including Investigator (involved in post-marketing product safety assessment and also serving on a legislative Project Team at the Ministry of Health, Labour and Welfare) and International Regulatory Planning and Coordination Officer. 
Brian Baker is a Senior Associate at Shobayashi International Patent & Trademark Office in Tokyo.
Organiser: EU-Japan Centre for Industrial Cooperation - Brussels Office
Moderator: Luca Escoffier is a Project Manager of the EU-Japan Technology Transfer Helpdesk