Defining and Implementing Quality in Clinical Investigations from Design to Completion
Venue: Washington Marriott Hotel
|Event Date/Time: May 10, 2007||End Date/Time: May 11, 2007|
As clinical investigations become more complex and global, FDA must continue to evolve and modernize the oversight and monitoring of research. In June 2006, FDA announced the BIMO Initiative, which specifically addresses concerns surrounding the protection of human subjects and the integrity of data in clinical trials (www.fda.gov/bbs/ topics/NEWS/2006/NEW01396.html).
FDA continues to seek input from clinical researchers and all other revel ant parties on the challenges of and potential solutions for the establishment of an integrated approach to data quality, data integrity, and human subject protections.
•FDA speakers from CBER, CDER, CDRH, CVM, OC, AND ORA
•Featured speakers/panelists from Academia, AAMC, ACRO, ADVAMED, BIO, CDISC, Data Quality Research Institute, MHRA, NIH, AND PhRMA.