Micro-Credential in Regulatory Affairs
  • Type Validation
  • Level Intermediate
  • Time Months
  • Cost Paid

Micro-Credential in Regulatory Affairs

Issued by UNC-Chapel Hill

The badge earner can: Describe the origins of medical product laws and regulations; Recognize key US and international authorities, organizations, and standards involved in the regulation of medical products; Describe types and subtypes of drugs, biologics, medical devices, and combination products; Summarize critical regulations impacting medical products; Explain how regulatory professionals support medical product development and postmarket compliance in the US and key international markets.

  • Type Validation
  • Level Intermediate
  • Time Months
  • Cost Paid

Skills

Earning Criteria

  • Complete a 15-week, post-bacalaureate level course on the Fundamentals of Regulatory Affairs consisting of 75 hours of asynchronous e-learning content, supplemental videos and reading assignments, discussion forum prompts, quizzes, and a final exam.
  • Complete 15 graded quizzes and a graded final exam, and respond to 14 graded discussion forum prompts. Score grade of at least 80% based on a weighting of 50% for quizzes, 25% for the final exam, and 25% for discussion forum prompts.