;   Medical Translation Insight: Best practices for translating Japanese regulatory submissions - ForeignExchange Translations

Many medical device companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that U.S.-based companies often do not know exactly what was submitted to the government, which can have serious implications.

The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors and reviewers, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.

Our own Jason Heaton is co-presenting a webcast with Minori Nakano-Carlsson of Medtronic on the topic of Japan regulatory submissions. The June 8th webcast is being sponsored and hosted by the Regulatory Affairs Professional Society (RAPS).

Jason and Minori-san will discuss how regulatory documentation gets translated, look at specific approaches companies take for their Japan dossier creation, identify the problems with the usual approaches, and present best practices for creating consistent, accurate and timely submissions. You can sign up for the 90-minute Webcast on the RAPS website: www.raps.org/Education-amp-Training/Webcasts/RAPS-Webcast-8-June-2011.aspx.

Jason presented on a similar topic for FX Conferences. If you can't make the RAPS Webcast, download his past audio conference instead.

Find out more about ForeignExchange's specialized Japanese translation services for medical device and pharmaceutical companies.


Post a Comment


Services | Resources | Company | Contact Us | Blog | Home

(c) Copyright 2010, ForeignExchange Translations, Inc.