DUBLIN--(BUSINESS WIRE)--The "Japan Regulatory Compliance Requirements for Life Science Products" conference has been added to ResearchAndMarkets.com's offering.
Course "Japan Regulatory Compliance Requirements for Life Science Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
Course Objective:
- 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.
For more information about this conference visit https://www.researchandmarkets.com/research/6mf5cx/two_day_course?w=4
