Past event: Japan Regulatory Compliance Requirements for Life Science Products

This 2-Day seminar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law (PAL) into the Pharmaceuticals & Medical Device Law (PMDL) and the country's latest update to GMP requirements.

The information presented will help you gain a comprehensive understanding of the Regulatory Structure, Product Classification, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals, GMP requirements and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running clinical studies, the importance of partner selection and also add the cultural knowledge needed for success in-country. The recent changes made by PMDA to be more sponsor and applicant-friendly, along with the impact this has had on dossier review times, will be shared. Real world experiences on actual interactions with the Agency, since these changes have been implemented, will also be discussed.

Course Objective:

Attendees will leave this Course clearly understanding the Regulatory Procedures necessary to be successful in getting your products to market in a timely fashion. This Course has been updated to provide participants with competitive insight into:

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

Who will benefit:

This seminar will benefit Project Team Members, whose specific functional discipline comes from:

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