Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products is a seminar that covers topics such as:

  • Who can legally register Life Science products in Japan
  • The impact of the PAL to PMDL Law change to applicants
  • When will additional clinical trials be needed on products and on which ones
  • If you want to be the legal License holder, what will you need: establishment office & personnel type
  • How does a Japanese CTD submission differ from ICH requirements
  • Will Japan accept global, clinically-developed data
  • Japan`s Medical Device classification procedures and regulatory pathways
  • What is required to register a Medical Device in Japan
  • What are your post-marketing responsibilities as a License Holder
  • Can you expect a GMP inspection of your facility by PMDA staff; updates to GMP Regulation & Guidelines
  • How best to work with the Authorities from a Business and Cultural Aspect

Japan: Regulatory Compliance Requirements for Life Science Products brings together:

  • Quality Assurance
  • Clinical Operations Staff
  • Regulatory Affairs Personnel
  • Monitors / CRAs
  • Global Supply Chain personnel
  • Pharmacovigilance Reporting personnel
  • Global Business Development personnel
  • Manufacturing personnel
  • Country Managers
  • Commercial Management
  • CRO`s, Consultants


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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