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.
The 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will go into the unique post-market challenge of change management facing the Foreign Manufacturer when dealing with its MAH counterpart in Japan. In addition, this session will go into the process steps and communications for regulatory (PMDA) notification in case of "significant" changes. Case studies and best practices will be explored, particularly with respect to "two-way" communication between the MAH and the manufacturer.
Areas Covered in the seminar:
- 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.
- Case studies of actual JPAL change processes.
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.
