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.
- Learn the essential activities and regulatory requirements involved in Phase IV clinical trials
- Discover strategies for extending a drug’s life cycle following market approval
- 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
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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.
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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.
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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
Justify This Training
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