This JPAL training will emphasize on Japanese Pharmaceutical Affairs law with respect to - Classification, device approvals, clinical data, MAH (Marketing Authorization Holder),foreign manufacturer accreditation,QMS,post-market complaints & vigilance
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.
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.Course Provider
Phil Smart,
