CDISC to Host 2016 Japan Interchange in Tokyo

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Japan PMDA, US FDA, Industry and Academia Participating to Help Develop “Smarter Research to Unlock Cures”

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High-level discussions will touch on critically important subject matter, such as the need to implement standards at the beginning of the research process, and the latest regulatory requirements for using CDISC standards that go into effect this year.

The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the participation of high-level representatives from the Japan PMDA, US FDA, industry and academia at the 2016 CDISC Japan Interchange. Presentations and discussions will address how CDISC standards help format data from clinical trials so that it can be shared and compared, ensuring “Smarter Research to Unlock Cures” to achieve faster breakthroughs for treating diseases. The CDISC Japan Interchange conference days are 02 - 03 June 2016 at the University of Tokyo in Tokyo, Japan.

“The 2016 CDISC Japan Interchange will bring together major players in the field of medical research, including representatives from academic research organizations, pharmaceutical companies, and global regulatory agencies, to discuss how the use of CDISC standards enables ‘Smarter Research to Unlock Cures,’” said Dr. Rebecca Kush, CDISC CEO. “High-level discussions will touch on critically important subject matter, such as the need to implement standards at the beginning of the research process, and the latest regulatory requirements for using CDISC standards that go into effect this year.”

Dr. Makoto Suematsu, President of the Japan Agency for Medical Research and Development (AMED) will deliver the keynote address. He has nearly 30 years’ experience in medical research and academia. Prior to his role with AMED, Dr. Suematsu held the position of Dean of the Keio University School of Medicine. His presentation, “The AMED Mission: The Impact of Sharing Medical Data,” will take place 02 June 2016.

The 2016 CDISC Japan Interchange will also include presentations from the Japan PMDA, U.S. FDA, Japan Pharmaceutical Manufacturers Association (JPMA), the Japan CRO Association (JCROA), members of the CDISC Board of Directors, and senior CDISC staff. The event will feature sessions focused on best practices in CDISC standards implementation and regulatory submissions; all sessions will offer simultaneous translation in Japanese and English. For more information about specific presentations and panel discussions, please view the final program on the CDISC website.

About CDISC - CDISC is a 501(c)(3) global non-profit charitable organization that streamlines research and enables connections to healthcare through the development of clinical research data standards. CDISC has developed a suite of standards to support clinical research from protocol through analysis and reporting, including therapeutic area specific standards for over 25 disease areas. CDISC standards make it possible for data to speak the same language, empowering simple data collection and private sharing that makes the most of the valuable information offered by patients participating in research studies around the globe. Using CDISC standards from the start of studies enables Smarter Research to Unlock Cures, saving ~60% overall in terms of time and resources to conduct research. CDISC is the patient’s advocate, creating therapeutic area data standards that advance medical product development and various types of clinical research.

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Andrea Vadakin, Director of Communications and Public Relations
CDISC
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