FDA's new web-based Training explains FDA Drug Regulatory Work

Many people from pharmaceutical industry all over the world want to learn about the regulations and processes of FDA's Center for Drug Evaluation and Research (CDER). CDER reviews applications for new and generic pharmaceuticals and manages the respective cGMP regulations. In the past years, CDER has organised CDER Forums twice a year. Those meetings were made for international drug regulatory authorities with the aim to give regulators first-hand information on how "CDER organizes the drug review process and carries out its mission of ensuring the safety and efficacy of human drug products in the United States".

Now, a new tool has been developed: the "CDER World", containing free e-learning modules with information about how CDER works. The respective modules deliver information based on the CDER International Forum series.

The following e-learning courses are currently available in CDER World:

  • World of Compliance
  • World of Generic Drugs
  • World of New Drugs

Each module contains a section of Frequently Asked Questions from International Forums.  From time to time, as CDER receives questions based on these modules, the modules will be updated or expanded and new modules will be developed to bring important information to those interested in the FDA and CDER. In some units of the modules, it is possible to choose between an abridged and a comprehensive version.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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