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Understanding the JPAL (Japanese Pharmaceutical Affairs Law): Comprehensive Training Package (5 Courses)

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This package of 5 training courses is meant to give an exhaustive and in-depth understanding of the Japanese Pharmaceutical Affairs Law (PAL) including the 2005 revisions which are now in force.

Speaker
Instructor: Phil Smart
Product ID: 701294

For medical device and pharmaceutical manufacturers, the 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. It gives an ample opportunity for non- Japanese companies to have a better presence in Japanese market and provide manufacturing services to its pharmaceutical industry. The company which moves first gets the advantage. It becomes essential to understand the law and its implication with respect to few important changes like submission of Drug Master Files by non-Japanese companies and the freedom of Japanese manufacturers to outsource their manufacturing, changes to physician-sponsored INDs, QMS requirements placed on the foreign manufacturer, relationship between the foreign manufacturer and the MAH/DMAH, post-market challenge of change management facing the Foreign Manufacturer etc.

ComplianceOnline brings to you this unique set of 5 webinars which will deal with all the above aspects of JPAL. Register for the entire set of courses at an affordable price and have your team up to date about the changes and make a difference.

Part 1:

Japanese PAL – Navigating the Japanese Pharmaceutical Affairs Law (Rec Version available)

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.

Areas Covered in the Webinar:

Part 2:

Japanese PAL – Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder) (Rec Version available)

This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).

Areas Covered in the Webinar:

Part 3:

Japanese PAL – JPAL QMS requirements in Ordinance 169 and differences to ISO 13485 (Rec Version available)

This JPAL (Japanese Pharmaceutical Affairs Law) QMS will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

Areas Covered in the Webinar:

Part 4:

Japanese PAL – JPAL change notifications and reporting between the foreign manufacturer, MAH and PMDA (Live & Rec Version available)

This JPAL (Japanese Pharmaceutical Affairs Law) training will go into the unique post-market challenge of change management facing the Foreign Manufacturer when dealing with its MAH counterpart in Japan.

Areas Covered in the Webinar:

Part 5:

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers (Live & Rec Version available)

This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.

Areas Covered in the Webinar:

Panelist Profiles:
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.

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Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email editor@complianceonline.com or call +1-888-717-2436(Toll Free).

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