17 January 2012

FDA CDER Small Business Update - Electronic Source Documentation in Clinical Trials Webinar

FDA CDER Small Business Team will present the webinar entitled Electronic Source Documentation in Clinical Trials, On Monday, January 23, 2012 at 11am (ET).  In this webinar they will discuss about the 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 will be 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

Call in numbers (listen only):

  • Domestic: 1-888-946-6301
  • International: 1-312-470-0190
Password (verbal): FDA

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