FDA compliance

The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC*) is charged with reviewing drug advertising and promotional materials to make sure that information provided to the public is not false and misleading. Materials are reviewed both before and after release to the public and pharmaceutical companies can lose significant amounts of money revamping a program to comply with DDMAC rules. In addition, Warning Letters sent by the FDA are made public and receiving these letters can damage a company’s reputation.

I created a proposal for an elearning solution designed to help marketing communications specialists develop FDA-compliant materials. I envisioned that modules would be part of a larger website modeled on Thiagi’s four-door approach with a bit more scaffolding as option for those who prefer a more linear approach. The website would include a cafe (discussion center), exploration center (providing scenario-based learning experiences), a challenge center (providing assessment modules), and library (resource collection). The "start" hub of the environment would provide learners with orienting materials and a suggested learning path they could take if they needed more structure.

 

*DDMAC is now the Office of Prescription Drug Promotion or OPDP

learning environment

participating patient navigation

This rapid prototype presents a draft for training exploration and assessment modules.

You can also view a presentation describing the
need and approach I took here.