Japan: Regulatory Compliance Requirements for Life Science Products 2018

Topics

• 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

Who should Attend

• 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