Two Day Seminar: Japan Regulatory Compliance Requirements for Life Science Products - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--Jun 14, 2018--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.
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.
For more information about this conference visit https://www.researchandmarkets.com/research/g9q86t/two_day_seminar?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20180614006231/en/
Laura Wood, Senior Manager
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KEYWORD: ASIA PACIFIC JAPAN
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY
SOURCE: Research and Markets
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PUB: 06/14/2018 04:40 PM/DISC: 06/14/2018 04:40 PM