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 highlights various aspects of drug regulation.
These focused webinars 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 Monday May 13, 2013, the CDER Small Business Assistance Program presented a webinar entitled What's New with the 1571 Form?
This Webinar acquainted participants with recent changes that have been made to FDA Form 1571 which accompanies all Investigational New Drug Application (IND) submissions. We provided an overview of the changes that were made and then walked participants through the various fields of the form, populated with mock data, while providing instructions as to what information is to be captured in each field. Time for questions from participants were allotted at the end of the Webinar.
Our presenter was Kay Schneider who is a senior project manager in the office of the Associate Director for Review Management (ADRM) in the Immediate Office of the Director, Center for Biologics Evaluation and Research (CBER), FDA. In her position as senior project manager, she recently took a lead role in the development of CBER’s new PDUFA V implementation process. She continues to serve as lead on several Center-wide and inter-Center committees that focus on policy development and business process implementation. Prior to joining the ADRM CBER, she was the Therapeutic Biological Products expert in the Regulatory Affairs Team (RAT), Office of New Drugs Immediate Office (OND IO), Center for Drug Evaluation and Research (CDER). Ms. Schneider earned a M.S. Degree in Neurophysiology from the University of Maryland at Baltimore, and a B.S. Degree in Biological Sciences from the University of Maryland, College Park.
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