FDA Drug Compliance
ARLINGTON, VA, DECEMBER 18, 2009: VarnerMiller, a training and documentation firm headquartered in Mount Pleasant, SC recently completed a course for the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). The 1.5 hour, web-based course went live on December 18, 2009 and is targeted for a cadre of pharmaceutical manufacturers who market unapproved drugs.
Over the past few years, the FDA has worked to identify and prioritize actions regarding unapproved drugs that have safety concerns, lack effectiveness, or are health frauds in order to uphold its mission of assuring that safe and effective drugs are available to the American people. This approach was intended to be implemented without imposing undue burdens on health care and was applied uniformly against all companies, large and small, that market these unapproved drugs.
In an effort to help explain the drug approval process to pharmaceutical companies, FDA/CDER turned to VarnerMiller to develop a course for manufacturers. The course utilizes video, motion graphics, and 3-D modeling to explain the routes to drug approval. VarnerMiller’s use of industry standard, adult learner focused, training development coupled with innovative approaches work together to engage learners and increase retention.
The project was coordinated through VarnerMiller’s Arlington Office and was awarded through their Office of Personnel Management, Training and Management Assistant Contract. The contract exists to develop training and human capital solutions for government agencies through an expedited contracting process. Overall, the contract manages 500+ projects annually, supports 100+ government agencies, and utilizes 30 pre-qualified commercial contractors.
The final course, Bringing an Unapproved Drug into Compliance, can be viewed at http://fdadrugcompliance.com/.
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