Drugs
CDER Small Business Electronic Documentation Webinar - January 23, 2012
The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series will highlight various aspects of drug regulation.
On Monday, January 23, 2012, we presented our webinar entitled Electronic Source Documentation in Clinical Trials, which reviewed regulatory requirements for electronic records and signatures when used in Clinical Investigations and provide practical concerns to keep in mind when preparing for and performing Clinical Investigations.
Dr. Sean Kassim was our presenter. Since April 2011, Dr. Sean Kassim has served as the Acting Team Lead for the Informatics and Infrastructure Team (I&I) under the Assistant Director for Regulatory Science, Intelligence, and Prioritization at the Office of Scientific Investigations (OSI, formerly DSI), Office of Compliance, Center for Drug Evaluation and Research, FDA.
As part of the I&I team he addresses clinical research concerns involving Part 11 and electronic record keeping, works on process improvements, and contributes to the development of models for inspection site selection.
He joined FDA in 2008 in the Bioequivalence and Good Laboratory Practices Branch at the then Division of Scientific Investigations, where he coordinated, reviewed, and performed inspections of clinical and bioanalytical sites performing bioequivalence and bioavailability studies in support of new and generic drug applications
Electronic John Hancocks: E-signatures, e-records replace paper
View Presentation here: https://collaboration.fda.gov/p44087880/
Download Presentation Slides: Electronic Source Documentation in Clinical Trials (PDF – 370KB)
For More Information: http://www.fda.gov/smallbusinessdrugs
