BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
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.
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
Certificate Requirements
- View entire course
- 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.
A digital strategy can no longer lie within a siloed digital or innovation team. It’s critical to integrate digital across the enterprise to maintain a competitive edge.
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.
The Regulatory Process provides a summary of the regulatory bodies involved in approving both small molecule drugs and biologics.
