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Essentials of Regulatory Affairs


Description

This course provides an essential introduction to regulatory affairs, covering key principles, guidelines, and compliance requirements in the life sciences industry. Participants will gain an understanding of regulatory frameworks, product approvals, and the role of regulatory professionals in ensuring compliance with global health authorities. Ideal for beginners or professionals looking to expand their knowledge of regulatory processes.


Course Content: 

  • Introduction to Regualtory Affairs
    • Quiz Introduction
  • FDS’s Origins
    • Quiz FDA
  • Fundamentals and the Pre-submission Phase
  • Final Test


Content
  • Introduction to Regulatory Affair
  • FDA Origins
  • Pre-submission Phase
  • End Test - Regulatory Affairs
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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