REGULATORY
PMDA Announces Results of Pilot Study on Electronic NDA Submissions Using CDISC Standards
The Pharmaceuticals and Medical Devices Agency (PMDA) announced on March 27 the results so far of a pilot study being conducted to prepare for the introduction in FY2016 of electronic data submission using CDISC (Clinical Data Interchange Standards Consortium) standards,…
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REGULATORY
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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.…





