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

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:

• 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.

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:

• The MAH/FM relationship in a "Japan-centric" scheme.
• Background and regulatory basis of the Quality Interface Agreement via Ord. 136 (GQP).
• Contents of the QAI including:
  • Scope and organizational interfaces.
  • Technical requirements.
  • Periodic verification.
  • Transportation and delivery.
  • Change control.
  • Post-market support and field actions.
  • Clinical trial audits and certification.
  • CAPA.
• Additional considerations including internal audits, nonconformance management, record retention.
• Leveling the playing field through best practices such as MAH representation, cross-functional audits and strong communication.

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:

• Overview of QMS requirements within the JPAL.
• The Foreign Manufacturer Accreditation process.
• Ministerial Ordinance 169 (general QMS - Medical Devices).
• Ministerial Ordinance 179 (Pharmaceuticals).
• Ministerial Ordinance 2 (Buildings and Facilities).
• Key Differences and Similarities between Ordinance 169 and ISO 13485.
• Ministerial Notification YAKUSHOKUKANMA 0330001.
• Special considerations for a successful PMDA audit.
• Internal Audits to cover JPAL, Ord. 2, 169 and 179.

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:

• Overview of Change Management and Regulatory Reporting within the JPAL.
• Key interfaces between MAH and the Foreign Manufacturer and the PMDA.
• Change mangement process as viewed from the MAH.
• Change mangement process as viewed by the Foreign Manufacturer.
• Best practices combining both view points.
• What is a "significant" change?
• Reporting requirements placed on the MAH.
• Two-way communication - the key to JPAL success.

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:

• Undertanding Japanese culture in context of JPAL.
• Risk adversity in the MHLW, PMDA and filtering down to the MAH.
• Language: Translations, interpretations and resulting gaps.
• Technical differences - How to respond and persevere.
• Culture differences - Sometimes we just have to go along.
• Submission data - Best practices for common understanding.
• Complaint handling between MAH and Foreign Manufacturer.
• Importance of Packaging in Japan.
• Detection of Foreign Matter and its impact on Japanese perception.
• Dealing with distributors and Japanese sales people.
• Dealing directly with the Japanese customer.

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.