Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course helps participants understand the U.S. regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, biologicals, and medical device products. Participants will gain high-level knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, and post-marketing requirements. This is an important course both for those entering the biomedical profession and for those already in the profession to learn more about the laws governing this industry.
- Examine FDA laws and the history of why they came into place
- Navigate key regulations that pertain to drug, biologic, and device development
- Describe how the FDA is organized
- Describe the roles and responsibilities of the FDA
- Navigate regulatory pathways for investigational products
- Regulatory Affairs Professionals
- Clinical Research Professionals
- Research and Development
- Manufacturing
- Project Management
- Those who want an introduction to the FDA's legislative process and background
Meredith Brown-Tuttle, R.A.C.
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1.5 hours; 12:00 - 1:30 p.m. Eastern
February 15, 2011