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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

Four things we learned at CDISC Asia/Japan Interchange 2014

Posted by Fiona Hartley on Aug 19, 2014 11:02:38 AM

Our CEO, Mark, will go to incredible lengths in search of new CDISC knowledge. Last week, he travelled 5,771 miles to attend this year’s CDISC Asia/Japan Interchange in Tokyo. Between all the sightseeing, sushi and sake, he was able to seriously indulge his CDISC otaku side with some of the leading regulatory experts from around the globe. A diverse list of distinguished speakers and attendees participated in what Partha Chakraborty, Asia-Pacific CDISC Coordinating Committee Chair, called a “game-changer in the Asia-Pacific region for CDISC awareness and standards implementation”.

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Topics: CDISC, CDISC International Interchange, Conferences & Events, CROs, EDC, Japan