Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

Instructor: Phil Smart
Product ID: 701292
  • Duration: 90 Min
This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

The 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese. All too often the communication gap widens, even when seemingly cut-and-dry technical issues are on the table. Through such things as basic risk adversity, language gaps, technical interpretations or cultural bias, the foreign manufacturer of medical devices often feels powerless to make quick and logical decisions to best meet the needs of the Japanese MAH, customers, distributors and regulators.

Areas Covered in the seminar:
  • 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.
  • Case studies of actual issues and their resolutions.

Who Will Benefit:
  • This webinar will provide valuable assistance to quality, regulatory, sales 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.

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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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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