How to Standardize Image Acquisition, Transfer, and Analysis.
Horsham, PA (Vocus) August 26, 2008
The Drug Information Association (DIA), in collaboration with FDA, the Medical Imaging Contrast Agent Association (MICAA), the Council on Radionuclides and Radiopharmaceuticals (CORAR), PhRMA, and the American Medical Informatics Association (AMIA), will host Medical Imaging Continuum: Path Forward for Advancing the Uses of Medical Imaging in the Development of New Biopharmaceutical Products (October 2-3; Bethesda, MD)
This workshop will provide updates on the harmonization and standardization of the key elements required to meet the FDA review process and Proposed Draft Regulatory Guidance of 2011. This effort is currently in progress with PhRMA, the Extended PhRMA Imaging Group, CORAR, MICAA and many other stakeholders who are shaping best practices for standardizing medical imaging in clinical trials, including academia, professional imaging societies, non-profit consortia, governmental agencies, and regulatory authorities.
Attendees will discuss "Metrics for Quantifying the Quality of Imaging Enterprises in Clinical Trials" and "How to Standardize Image Acquisition, Transfer, and Analysis." Potential outcomes will include:
- Endorsement of a rigorously defined metrics that quantify the quality of imaging enterprises in biopharmaceutical development;
- An explanation of the issues surrounding the quantification of adjudication rates across therapeutic areas and imaging technologies;
- Harmonization of imaging as a quantitative measure of drug-induced changes in multi-center clinical trials; and
- The adoption of a standard, open-source, internet-based application for transferring data from sites of acquisition to central repositories.
"Working alongside experts from academia, professional imaging societies, non-profit consortia, and governmental agencies, meeting attendees will help to shape best practices for standardized medical imaging in clinical trials," notes Program Chair P. David Mozley, MD, Senior Director, Imaging, Merck Research Laboratories.
About the Drug Information Association (DIA)
DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, and Mumbai, India, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.