BIO Professional Development
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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.
- 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
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- Pass course exam with a 70 percent
- Complete the course evaluation
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.
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.
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.
Learn how to bring a drug successfully to market.
Do you need to understand the drug development process, including details about a drug's life cycle from its discovery through post-marketing studies? This is the course for you.
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