FDA Expands Online Learning

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 and continuing education 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. Other eLearning programs focus on compliance, generic drugs, and new drugs. Each educational session includes a list of Frequently Asked Questions from international forums, which CDER updates periodically.
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 online sessions can be viewed at any time through the website.

It’s nice to see that FDA, and CDER in particular, are putting this basic information out there so that industry and other regulatory bodies can have a deeper understanding of its processes. Many organizations on the regulatory and industry side are increasing their level of transparency and sharing of information-a feat that has been hard to accomplish in this patent-driven environment. Harmonization of regulatory reviews and marketing authorizations will go a long way towards streamlining the global pharmaceutical development and manufacturing marketplace. This online learning program is one of many forward steps in that direction.