Many companies that do 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 often the US-based companies then don't 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, 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.

This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.

This audio conference covers:

• How regulatory documentation gets translated
• How to achieve and maintain consistency between English and Japanese submissions
• Preparing localization-friendly submission dossiers
• Developing a respectful, trusting, collaborative process with Japanese colleagues that leverages expertise on both sides

About the speaker:

Jason Heaton is a 10-year veteran of the localization industry, and has seen both sides of the business as a client and vendor. Jason began his career as a technical writer, then moved on to become a project manager at a small translation agency in Minneapolis. After that he joined a large medical device manufacturer, working in both the technical communications and regulatory affairs departments. Jason spent his first three years at medical translation specialist ForeignExchange as an account manager, and currently serves as its marketing manager. Jason is a frequent speaker at RAPS and other industry events.

Who should attend?

• Regulatory Affairs Managers
• Regulatory Affairs Associates
• Clinical Managers
• Clinical Research Associates
• Compliance Professionals

To learn more about Japanese translations, please visit ForeignExchange Translations website by clicking here