CDISC to Host 2016 Europe Interchange in Vienna to Enable “Smarter Research to Unlock Cures”

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U.S. FDA, EMA, and Japan PMDA Participating. These global regulators will provide discussion around regulatory requirements for use of the CDISC standards that go into effect starting this year.

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The event will provide a venue to discuss the successes, challenges, and opportunities for collaboration among stakeholders in Europe and around the globe.

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) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), at the 2016 CDISC Europe Interchange. These global regulators will provide discussion around regulatory requirements for use of the CDISC standards that go into effect starting this year. Also participating in the conference will be CDISC experts and innovators from industry and academia. This educational and networking conference will be held 25-29 April in Vienna, Austria.

“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 unlock cures for patients,” said Dr. Rebecca Kush, CDISC CEO. “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 2016 Europe Interchange will include case studies and best practices in therapeutic area standards implementation and discussion around new and upcoming therapeutic area standards. The CDISC Therapeutic Area 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. The event will also offer the largest number of CDISC Education courses in one place in Europe, as well as engaging presentations from respected industry professionals.

Keynoting the 2016 Europe Interchange will be Dr. Amanda Rojek (B.App Sci, MBBS, MSc), a medical doctor with an academic interest in the medical response to humanitarian crises, especially disease outbreaks. Most recently, Dr. Rojek was the field project manager for a clinical trial of an experimental Ebola therapeutic, conducted in Sierra Leone during the West Africa Ebola outbreak. Dr. Rojek is a Rhodes Scholar at the University of Oxford where she is completing a thesis on improving the patient oriented research response to emerging infectious disease outbreaks.

Also presenting a keynote address will be Dr. Scott Wagers, CEO of BioSci Consulting and Founder of the Collaborative Research Consortia Leaders Group. Dr. Wagers has been collaborating with CDISC through the Innovative Medicines Initiative (IMI) eTranslational Research Information Knowledge System (eTRIKS) Project. He will present “Meaningful Involvement of Patients in Life Science Multi-Stakeholder Initiatives.”

“I am looking forward to an exciting Europe Interchange with plenty of opportunity to network with industry colleagues,” stated Peter Van Reusel, Chairman of CDISC E3C (European CDISC Coordinating Committee). “There will be interesting and novel viewpoints on both the creation and implementation of data standards in our environment today and tomorrow.”

On the evening of 27 April, CDISC will host its Networking Event at the Piaristenkeller Monastery Cellar in the heart of Vienna. Participants will enjoy a fine Austrian dinner and wine tasting experience while touring the 300-year-old wine cave and the Austrian Emperor Museum.

The 2016 Europe Interchange will take place at the Austria Trend Hotel Savoyen Vienna · Rennweg 16 · A-1030 Wien · Vienna, Austria.     

CDISC Contact: Nicole Harmon - 512.968.0080 / nharmon(at)cdisc(dot)org

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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