Experts from FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), the University of Maryland and the University of Pennsylvania will provide a deep dive into the scientific background and practical methodology needed when conducting clinical trials.
In this intensive course, attendees will learn FDA regulations, ethical considerations, and the scientific principles to help them understand what is important when conducting clinical trials and preparing a submission for FDA review.
About the Training Course
Topics include:
- Preclinical and clinical science
- Statistical structure of trials
- Safety and ethical requirements
- FDA regulatory requirements related to the performance and evaluation of clinical studies
- Non-clinical, early clinical, and phase 3 studies
- Issues in the design and analysis of trials
For more info: https://www.fda.gov/training/clinicalinvestigatortrainingcourse/default.htm