Austin, Texas (PRWEB) March 11, 2014
The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the participation of high-level speakers 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 leaders from industry and academia at the 2014 CDISC Europe Interchange from 7-11 April in Paris, France.
Dr. Frank Rockhold, Senior Vice President and Head of Global Clinical Safety and Pharmacovigilance at GlaxoSmithKline, and former Chair of the CDISC Board of Directors will be presenting on Data Sharing during the opening Plenary session of the Interchange.
Dr. Fergus Sweeney, Head of the Inspections and Human Medicines Pharmacovigilance Division of the EMA will give an update from the EMA and participate in a panel discussion during the closing session of the conference.
Yuki Ando, Senior Scientist for Biostatistics at the PMDA, leader of the CDISC implementation activities at PMDA and an Observer on the Japan CDISC Coordinating Committee (J3C), will give an overview of CDISC standards implementation plans at the PMDA.
Mary Ann Slack, Deputy Directory of the Office of Strategic Programs at CDER at the FDA, will present on eStudy Data and the FDA. Ms. Slack will also participate in the closing session panel discussion and Q&A session.
Dr. Ron Fitzmartin, Senior Advisor of the Data Standards Program in the Office of Strategic Programs at the Center for Drug Evaluation and Research (CDER) at the FDA, will present the new FDA regulatory guidance relevant to the use of CDISC standards for submissions and on the development of Therapeutic Area standards.
Dr. Dipak Kalra, Professor of Health Informatics and Director of the Centre for Health Informatics and Multi-professional Education (CHIME) at the University College of London, and member of the CDISC Board of Directors, will give the opening remarks and participate in the panel discussion for the closing session of the conference. Dr. Kalra will focus on standards in Europe and particularly the use of electronic health records for research.
Peter Milligan, Vice President of Clinical Platforms Transformation at GlaxoSmithKline and member of TransCelerate BioPharma, Inc. (“TransCelerate”), will give an overview on TransCelerate during the opening session of the conference, and will participate in the closing panel and Q&A discussion.
“With such a large number of high-level speakers representing regulatory authorities, industry and academia from around the globe, we anticipate that this year’s CDISC Europe Interchange will be the most successful on record,” stated Dr. Rebecca Kush, CDISC President and CEO. “There have been significant advances in the use of CDISC standards by various regulatory agencies around the world this year. Having representatives from these agencies on-hand to present and respond to questions at this conference offers a fantastic opportunity for our attendees.”
In addition to the distinguished speakers listed above, CDISC anticipates participation from representatives from the EMA as well as presentations from those who submitted selected abstracts and are experienced users of CDISC in their organizations. There is still time to plan your attendance at the 2014 CDISC Europe Interchange. For further information on the speakers, topics and venue for this conference, please visit the CDISC website.
CDISC is a 501(c)(3) global non-profit charitable organization, with over 300 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.