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

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.

• 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.

• 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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