Overview
 Getting timely FDA approval, so products can get to market quickly, is the function of a Regulatory Affairs professional. Our Specialized Studies Program is designed to give these professionals a core competency in managing the regulatory process, FDA approval process, and an understanding of the product life-cycle.
Participants who complete the program will satisfy the Level I and II core competencies described in the RAPS Regulatory Affairs Professional Framework.
Specialized Studies Requirements
Candidates must possess a fundamental understanding of FDA regulations through Regulatory Requirements for Medical Devices, EECS X445.2, or Regulatory Requirements for Pharmaceutical Products, EECS X445.26; OR possess equivalent experience or education.
NOTE: Candidates choose either Regulatory Requirements for Medical Devices OR Regulatory Requirements for Pharmaceutical Products. Candidates that choose to take both courses may count one as an elective course.
The Specialized Studies award is provided upon successful completion of three required courses totaling 9 units, with a grade point average of “B” or better.
Note: Six credit units may be counted toward the Medical Product Development or Clinical Trials: Medical Device and Drug Development Certificate Program. |
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Program Benefits
- Prepare for a job transition into the Life Science Industry.
- Further your career as a Regulatory Affairs professional.
- Prepare to become a certified Regulatory Affairs Professional (RAC).
- Organize your company’s clinical and regulatory strategies.
- Establish an educational pathway for advanced education in FDA regulations, compliance, and policy.
Who Should Attend
This program is designed for individuals who ensure regulatory compliance and prepare submissions for their organization’s products for FDA approval. Job functions include addressing laws, regulations, policies and guidelines for regulated health products, medical devices, pharmaceuticals, biologics and biotechnology. |
