Regulatory 101: Navigating the Background, Laws, and Pertinent Regulations February 2011

Feb 15, 2011
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Course Description 

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.



Learning Objectives 

  • 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

Who Should Attend 

  • 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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Course Length Time 

1.5 hours; 12:00 - 1:30 p.m. Eastern

Course Dates 

February 15, 2011


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