CDISC Welcomes Global Regulatory Representatives, CDISC Experts and Innovators to 2015 CDISC Europe and Japan Interchanges

Share Article

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), as well as CDISC experts and innovators from industry and academia at the 2015 CDISC Europe and Japan Interchanges. These educational and networking conferences will be held 04-08 May in Basel, Switzerland, and 22-26 June in Tokyo, Japan, respectively.

News Image
CDISC is grateful to the European CDISC Coordinating Committee, the Japan CDISC Coordinating Committee and to all those who have contributed in making the CDISC Interchanges possible.

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), as well as CDISC experts and innovators from industry and academia at the 2015 CDISC Europe and Japan Interchanges. These educational and networking conferences will be held 04-08 May in Basel, Switzerland, and 22-26 June in Tokyo, Japan, respectively.

Representatives from the EMA, FDA and PMDA will be on-hand at the 2015 CDISC Europe Interchange to provide updates on the review processes from the perspective of their respective regulatory agencies. Additionally, this Interchange offers the singular opportunity to join a one-day “FDA Workshop,” where attendees will have the opportunity to experience the NDA/BLA submission and review process from end-to-end through the use of lecture, various media, demonstrations and hands-on activities.

At this Interchange, a wide selection of CDISC Authorized Education courses will be available. Courses to be offered include Healthcare Link, where attendees learn about integration profiles developed by CDISC and its sister organization, Integrating the Healthcare Enterprise (IHE), and how these profiles can bridge the gap between the EHR and EDC; the CDISC SEND Implementation course, which is designed for individuals in non-clinical and pre-clinical research; and courses on such Foundational Standards as SDTM, ADaM, CDASH and others. Online registration for the 2015 CDISC Europe Interchange ends 20 April 2015 and can be accessed here.

The 2015 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 at this event. The Japan Interchange will also have sessions focused on best practices in CDISC standards implementation and regulatory submissions, and all sessions offer simultaneous translation in Japanese and English.

CDISC Authorized Education courses will also be offered at the Tokyo conference, including such courses as SDTM Theory and Application, ODM Implementation, Define and Dataset-XML, Controlled Terminology, and ADaM Implementation. Online registration for the 2015 CDISC Japan Interchange will close on 08 June 2015 and can be accessed here.

CDISC is grateful to the European CDISC Coordinating Committee, the Japan CDISC Coordinating Committee and to all those who have contributed in making the CDISC Interchanges possible. This includes a number of dedicated exhibitors and sponsors, notably Accenture, who is continuing their diamond sponsorship of all global CDISC Interchanges. Sponsorship and exhibitor opportunities remain available for upcoming Interchanges, and this assistance allows CDISC to continue its mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. For more information, please visit the CDISC website.

ABOUT CDISC
CDISC is a 501(c)(3) global non-profit charitable organization, with over 350 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

Share article on socal media or email:

View article via:

Pdf Print

Contact Author

Andrea Vadakin, Manager of Public Relations
CDISC
+1 (316) 558-0160
Email >
@CDISC
since: 04/2009
Follow >
Clinical Data Interchange Standards Consortium (CDISC)
Like >
CDISC