Lost in Translation: Best Practices for Translating Japanese Regulatory Medical Device Submissions
8 June 2011
12:00–1:30pm EDT
Many 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 often the US-based companies 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.
This webcast 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.
Learning Level(s): Basic, Intermediate
Learning Objectives
Upon this webcast's conclusion, you should be able to:
- Explain how regulatory documentation gets translated
- Prepare localization-friendly submission dossiers
- Achieve and maintain consistency between English and Japanese submissions including dos and don'ts from a regulatory specialist perspective
- Describe the best and worst outcomes when the translation is done adequately or inadequately
- Develop a respectful, trusting, collaborative process with Japanese colleagues that leverages expertise on both sides
Who Should Attend
- Regulatory Associates
- Regulatory Management
- Compliance Specialists
- Translation Coordinators
Speakers
Minori Nakano Carlsson, MBA
Minori Nakano Carlsson has worked for Medtronic for more than six years in CRDM Regulatory Affairs. She currently manages CRDM International Regulatory Affairs. Minori holds an MBA from the University St. Thomas. Prior to joining Medtronic, she worked for Toyota Automobile in Japan and Prisma International.
Jason Heaton
Jason Heaton is a 12-year veteran of the medical localization industry, and has seen both sides of the business as a client and vendor. He began his career as a technical writer, and then moved on to become a project manager at a small translation agency. He later joined Guidant Corporation (now Boston Scientific), working in both the technical communications and regulatory affairs departments. Heaton is the marketing manager for ForeignExchange Translations.
Cost
Live Webcast Only: Members: $295 USD; Nonmembers: $369 USD
Webcast On-demand Recording Only: Members: $295 USD; Nonmembers: $369 USD
Live Webcast/On-demand Bundle: Members: $395 USD; Nonmembers: $469 USD
Cost is per site - unlimited participants!