Get Started
The Autumn 2009 program is no longer accepting applications
Next program starts: Autumn 2010
Details will be posted in Spring
Single courses may be available
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Understand the role of a medical products regulatory affairs specialist and the dynamic nature of the regulatory field. Learn how to locate regulatory information in key national and international sources. Grasp the laws and regulations that apply to the development, testing, and production of medical products, including biologics, drugs, biotechnology-derived therapeutics, vaccines, and medical devices (including in vitro diagnostics). Explore product development, manufacturing, post-marketing requirements, reporting, and enforcement.
What the Program Covers
- Roles and responsibilities of a medical products regulatory affairs specialist
- Organization and regulatory jurisdiction of the U.S. Food and Drug Administration
- Product approval process
- Post-market issues and requirements, including ongoing inspections
- General business, legal, and scientific concepts related to clinical trials
- Product liability, reimbursement, and environmental impacts
Benefits
You will gain the knowledge and skills necessary to be an effective regulatory affairs and compliance specialist.
Who Should Apply
Level: All Experience Levels
- Individuals who seek to expanded their understanding of regulatory affairs for the drug and medical device industry
- Individuals who want to enter or advance in the biomedical regulatory affairs field
If you have questions about your eligibility for this program, give us a call at 888-469-6499.
