Austin, TX – 30 March 2017 – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the participation of high-level representatives from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), and the Infectious Diseases Data Observatory (IDDO) at the 2017 CDISC Europe Interchange. Participating global regulators will provide discussion around regulatory requirements for use of the CDISC standards that went into effect at the end of last year. Also participating in the conference will be CDISC experts and innovators from industry and academia. This educational and networking conference will be held 24-28 April in London, England.
“The CDISC Europe Interchange brings together representatives from organizations interested in ensuring that clinical research data ‘speaks the same language,’ empowering simple data collection and sharing, improving medical research, regulatory science, and the development of therapies, all in the effort to foster smarter research to unlock cures for patients,” said Dr. Nicole Harmon, CDISC COO. “The event will provide a venue to discuss the successes, challenges, and opportunities for collaboration among stakeholders in Europe and around the globe, who are developing and implementing clinical research data standards and streamlining the biomedical research process.”
The 2017 Europe Interchange will include case studies and best practices around development and implementation of new and upcoming CDISC Therapeutic Area (TA) standards, including information on FDA-supported CDISC TA standards, which were included in the recently released U.S. FDA Study Data Technical Conformance Guide. These standards make it possible to share and compare data across studies and analyze clinical research findings to streamline development of medicines and treatments for specific disease areas.
Keynoting the 2017 Europe Interchange will be Dr. Hans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA). Dr. Eichler is responsible for coordinating activities between the EMA’s scientific committees and giving advice on scientific and public health issues. Also presenting a keynote address will be Laura Merson, Associate Director of the Infectious Diseases Data Observatory (IDDO). At the IDDO, Laura leads new initiatives in data sharing for emerging infections and neglected tropical diseases. As an executive member of the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), Laura has been integral in the development of standardized, open-access research protocols and data systems designed for outbreak response in collaboration with the World Health Organization (WHO).
“I am looking forward to an exciting Europe Interchange with plenty of opportunity to network with industry colleagues,” stated Peter Van Reusel, Chairman of the European CDISC Coordinating Committee (E3C). “There will be interesting and novel viewpoints on both the creation and implementation of data standards in our environment today and tomorrow.”
CDISC is grateful to all those who contribute to making CDISC Interchanges possible. CDISC extends special gratitude to Accenture for its fourth year Global Diamond sponsorship and to Omnicomm for their Global Ruby sponsorship of CDISC Interchanges. To learn more about this conference and ways to become involved with CDISC, please visit the Europe Interchange page on the CDISC website.
CDISC is a 501(c)(3) global, non-profit organization that develops data standards to foster smarter research and enable connections to healthcare. CDISC standards allow data to speak the same language, by providing common formats for data collection, data sharing and data analyses to make the most of the valuable information offered by patients participating in research studies around the globe, enabling researchers to discover new treatments, find breakthroughs, and unlock cures. CDISC standards are required for regulatory submissions to the U.S. FDA and Japan PMDA, are endorsed by the China CFDA, and are requested for use by the European Innovative Medicines Initiative (IMI). The suite of CDISC standards is freely available on the CDISC website.
CDISC is funded through the generous support of over 400 member organizations from pharmaceutical, biotech, clinical research organizations, regulatory agencies, academia, and healthcare, as well as through grants, authorized CDISC Education courses, events and charitable contributions. To find out more about how to support CDISC and get involved, please visit www.cdisc.org and www.unlockcures.org.