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Clinical Development 401: Phase IV
Clinical Development 401: Phase surveys the ongoing post-approval clinical assessments required by regulatory agencies. Learn how drug risk management is accomplished through detecting, assessing and reporting adverse effects using real-world data.
Clinical Development 401: Phase IV Course Trailer
Takeaways
- Purpose of Phase IV studies.
- Key limitations of pre-market studies and why post-market studies are an important complement to Phase I-III studies.
- Role of regulatory safety information reporting programs including MedWatch in US and EudraVigilance in Europe.
- In-depth look at Real-World Data (RWD) and Real-World Evidence (RWE) and their impact on safety.
- Identification of important real-world data sources
Download Course Syllabus
Clinical Development 401 Phase IV
Course offered by
Course Price:
$150 USD
BIO Member Price:
$120 USD
Course Length:
50 minutes
Course Level:
Advanced
Completion Period:
2 weeks
Course Format:
On-Demand
Certificate Requirements
- View entire course
- Pass course exam with a 70 percent
- Complete the course evaluation