[January 25, 2018]

Two Day Course: Japan Regulatory Compliance Requirements for Life Science Products (Tukwila, WA, United States - June 7-8, 2018) - ResearchAndMarkets.com

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 [PMD] 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 (News - Alert).

For more information about this conference visit https://www.researchandmarkets.com/research/6mf5cx/two_day_course?w=4

View source version on businesswire.com: http://www.businesswire.com/news/home/20180125006097/en/

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