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CDISC To Host 2016 Japan Interchange In Tokyo To Enable "Smarter Research To Unlock Cures"



5/10/2016 9:21:27 AM

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WHAT - The 2016 CDISC Japan Interchange will have presentations given by representatives from both the Japan PMDA and US FDA, followed by Q&A panel discussions with high-level participants from these regulatory authorities. Representatives from the Japan Pharmaceutical Manufacturers Association (JPMA), the Japan CRO Association (JCROA), members of the CDISC Board of Directors, and senior CDISC staff will also be presenting. The Japan Interchange will have sessions focused on best practices in CDISC standards implementation and regulatory submissions, and all sessions offer simultaneous translation in Japanese and English.

This year’s CDISC Japan Interchange will offer authorized CDISC Education Courses on a wide range of CDISC standards that enable beginning-to-end data collection, aggregation and reuse, all in Japanese.

WHY COVER - CDISC standards help format data from clinical trials in a way that can allow it to be shared and compared, ensuring faster breakthroughs for the treatment of diseases. At this conference there will be presentations from representatives of academic research organizations, pharmaceutical companies, global regulatory agencies and more that speak to the benefits of implementing these standards at the beginning of the research process. Regulators from the Japan PMDA and U.S. FDA will discuss upcoming regulatory requirements for use of CDISC standards that go into effect this year. Media and attendees will learn about these requirements and best practices in CDISC standards implementation and usage from leaders in Japan, the U.S. and Europe.

Keynote Address by Dr. Makoto Suematsu, President of the Japan Agency for Medical Research and Development (AMED), with nearly 30 years of experience in medical research and academia. Prior to this role, Dr. Suematsu held the position of Dean of the Keio University School of Medicine. His Keynote presentation, entitled, “The AMED Mission: The Impact of Sharing Medical Data,” will be held on 02 June 2016.

WHERE University of Tokyo, Japan
Ito Hall
7-3-1, Hongo, Bunkyou-ku Tokyo, Japan 113-0033

WHEN 30 May - 03 June 2016

WHO - CDISC is a global, nonprofit, charitable organization, and is considered the patient’s advocate, leading the charge for data synchronization so that patients participating in clinical research can be assured that their information contributes to a valuable cause and will not end up unused in silos. CDISC standards are considered the gold standard for medical research around the world. These data standards are used in more than 90 countries and are required by the U.S. FDA and Japan’s PMDA for evaluating new treatments for various diseases and afflictions.

CONTACT Andrea Vadakin, CDISC Director of Communications and Public Relations
Cell: +1-316-558-0160 | Email: avadakin@cdisc.org

Read at BioSpace.com

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