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Regulatory Affairs in Clinical Trials

Categories: Clinical Trials
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About Course

Understand the global regulatory framework for clinical trials, including FDA submissions, ICH-GCP guidelines, IND/NDA applications, and post-marketing surveillance.

What Will You Learn?

  • Understand the 4 Phases of Clinical Trials
  • Learn how protocols are developed and approved
  • Explore the role of ethics committees and informed consent
  • Understand monitoring, data handling, and reporting procedures
  • Know the roles of stakeholders like Sponsors, CROs, and Investigators

Course Content

Clinical Trial Foundations

  • What is a Clinical Trial?
  • History and Evolution of Trials

Clinical Trial Phases

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