Japanese PAL - Navigating the Japanese Pharmaceutical Affairs Law
Instructor:
Phil Smart
Product ID: 701276
- Duration: 90 Min
For medical device and pharmaceutical manufacturers, the 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will take you through the PAL, its key regulatory players, essential concepts, applicable ordinances, conformity assessment paths and associated compliance requirements. Particular attention will be placed on implications for the foreign medical device manufacturer, from pre-market submissions to post-market surveillance.
Areas Covered in the seminar:- Overview of the PAL.
- Roles of MHLW and PMDA.
- Applicable ordinances for GQP, GMP, GVP, etc.
- Role of the MAH in Japan and ties to the foreign manufacturer.
- JPAL Product classification.
- Shonin approval process.
- Ninsho 3rd party certification process.
- Acceptance of foreign clinical data.
- Clinical data and GCP.
- Foreign Manufacturer Accreditation.
- QMS and Ministerial Ordinance 169.
- Post-market complaint handling / vigilance.
Who Will Benefit:
- This webinar will provide valuable assistance to quality, regulatory and manufacturing associates, whose companies sell or plan to sell their medical or pharmaceutical products in Japan.
Instructor Profile:
Phil Smart, is a founding member and Regulatory Consultant of RA/QA International LLC. He serves as Consultant, Auditor and Instructor, covering medical device regulations and standards within the US, Europe, Canada and Japan. He has spent over seven years in Tokyo and is a former head of operations and medical device assessment activities for TUV in Japan.
He has been a European Notified Body Lead Assessor and Monitoring Auditor for over 15 years with auditing experience in a wide range of active and non-active medical device technologies.
More Training By Experts
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- International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan
- Risk Management and Internal Auditing: Effective quality audits with inclusion of ISO 14971:2007
- GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL
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