Monday, July 11, 2011
Human Drug Export Compliance Webinar from the FDA
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.
These focused webinars will support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.
On Thursday, July 14, 2011 at 11AM (EDT), we will present our next webinar entitled Human Drug Export Compliance which will focus on the regulations that govern the export of human drugs – both approved and unapproved drugs. The discussion will include topics such as the FDA Export Reform and Enhancement Act of 1996, Transportation and Exportation (T&E) and Export Certificates.
This presentation will be given by Bill Nychis, Senior Compliance Officer in the Import Operations Branch (IOB), Division of Import Operations and Recalls, Office of Drug Security, Integrity and Recalls, within the CDER Office of Compliance.