REGULATORY
MHLW Notifies of Guidelines on Use of Registry Data in Regulatory Submissions
The Ministry of Health, Labor and Welfare (MHLW) issued on March 23 guidelines on the use of real world data from actual clinical settings in regulatory filings. The guidelines on the “basic policy on the use of registry data in…
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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…





