Empowering professionals for over 24 years

Empowering professionals for over 24 years

Clinical Development 401: Phase IV  | CPE

Clinical Development 401: Phase IV  | CPE
  • Level: Advanced
  • CPE: 1.0 Credits
  • Time: 50 Minutes

Clinical Development 401: Phase IV explains what happens after drug approval, when real-world safety monitoring and life cycle management begin. Explore the FDA’s use of tools like MedWatch and the strategies companies employ to optimize, expand, and protect patients after launch.

  1. Learn the essential activities and regulatory requirements involved in Phase IV clinical trials
  2. Discover strategies for extending a drug’s life cycle following market approval
  3. Understand the differences in long-term safety insights between pre-approval trials and post-approval studies
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  • Overview
  • Agenda
  • Features
  • Justify This Training
  • FAQ

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Agenda

  1. Post-Approval Clinical Trials

    Highlights the purpose of Phase IV studies and provides an in-depth look at numerous study examples, including long-term safety and pharmacoeconomic studies.

  2. Pharmacovigilance and Post-Marketing Safety Follow-Up

    Explains the purpose and function of post-marketing pharmacovigilance systems, including MedWatch in the U.S. and EudraVigilance in Europe, which monitor drug safety.

  3. Real-World Evidence

    Discusses how regulatory authorities use real-world evidence to improve regulatory decisions.

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates

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