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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.

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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

Instructor 

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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