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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.

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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 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
Suggested Prerequisites
FLIP

Clinical Development 101: General Principles sets the stage for the entire clinical development process. Learn who conducts trials, how trials are conducted, and the various regulatory elements that must be performed throughout Phases I-IV trials.

Professional Certificate
FLIP

Clinical Development 201: Phase I explores the prerequisites, purpose, design, and conduct of Phase I trials. Topics such as bioequivalence, pharmacokinetics, pharmacodynamics, endpoints, selection of dose, and more are explained in detail.

Professional Certificate
FLIP

Clinical Development 301: Phase II/III considers the purpose, design, and conduct of Phase II and III clinical trials. Learn the various trial design approaches, endpoint choices, statistical considerations, and special regulatory designations.

Professional Certificate
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