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

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

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 aversity, 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.

Venue

Additional Information

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 aversity, 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.