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5 Talking Points from the Japanese CDISC Blueprint

Posted by Fiona Hartley on Aug 13, 2015 4:58:47 PM

It’s an exciting time to be involved in CDISC affairs in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) - the country’s equivalent of the US FDA - recently outlined its vision for accepting clinical data in CDISC format for new drug applications, starting in October 2016. And earlier this month, the Agency released its Technical Conformance Guide - the blueprint for CDISC submissions - in English for the first time.

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Topics: CDISC, Japan, PMDA

Formedix #DIA2015 Interviews: CDISC Standards Deadline Raises Bar for Japanese Firms

Posted by Fiona Hartley on Jul 1, 2015 2:59:54 PM

Ahead of this year's DIA 2015 Annual Meeting, Formedix commissioned a series of three interviews with some of our CDISC standards experts. In the second, our man in Japan Masahiro Hayashi talks about the country's looming CDISC deadline, and what it means for its pharmaceutical companies.

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Topics: CDISC, Define-XML, Japan, PMDA, SDTM