Medical Writing Careers in medical writing Clinical trial disclosure landscape and awareness in Japan

Volume 28, Issue 1 - Careers in medical writing

Clinical trial disclosure landscape and awareness in Japan

Abstract

While disclosure of individual clinical study reports (CSRs) is becoming common globally, this is not yet the case in Japan, where the national health authority does not require CSRs to be made publicly available. As CSRs of Japanese studies might be used for marketing applications in other countries and regions, Japanese pharmaceutical companies that would like to expand their market internationally need to prepare CSRs that can be used for global applications and disclosure. In this article, we introduce the current situation in Japan regarding disclosure of clinical study data.

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References

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Careers in medical writing
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Career shifts – surviving a change in geography
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Clinical trial disclosure landscape and awareness in Japan
News from the EMA
Regulatory Matters
Gained in Translation
In the Bookstores
Medical Devices
Journal Watch
Veterinary Medical Writing
Good Writing Practice
Medical Communication
Regulatory Public Disclosure
Out on Our Own
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