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Angie Drakulich was editorial director of BioPharm International.
This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.
FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational regulatory-based forum since 2005 to engage its international regulatory counterparts. This forum includes online learning courses on how the Center organizes its drug-review process in the US.
This month, CDER added a new program in drug safety to its “CDER World” platform for training and education. The new program includes information about the agency’s Office of Surveillance and Epidemiology. The forum meetings, held twice a year, are held through CDER World in a “live” format via the Internet in order to reach as many people as possible.
“The interest in these ‘live’ meetings has grown exponentially with FDA working in harmonization with countries around the world,” states the CDER World website. “Many more people than can be accommodated at these small meetings want to learn about the science, technology, regulations and processes CDER uses to accomplish its complex and challenging work.”
Other eLearning programs focus on compliance, generic drugs, and new drugs. Each educational session includes a list of Frequently Asked Questions from international forums. These questions are updated by CDER periodically.