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RAPS Japan conference wrap-up

RAPS Japan conference wrapupThe Regulatory Affairs Professional Society (RAPS) hosted a two-day conference last week, focusing on Japan regulatory filing. It was well attended by medical device and IVD company representatives and industry consultants.

The conference agenda covered diverse topics, from reimbursement strategies for IVD companies, to QMS applications, cultural tips for doing business in Japan and updates to the Pharmaceutical Affairs Law.

Jason Heaton of ForeignExchange Translations talked about establishing an effective process for creating Japan regulatory submissions, a topic that is on a lot of companies' minds. Feedback was positive and some good questions were raised: What about dialect differences? How is review handled? Who has ultimate responsibility for translation quality?

For more details on this topic, look for an article on a similar topic in the November issue of the RAPS Focus magazine.

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


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