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Description
This course prepares medically trained individuals to become new medical monitors and enhances the knowledge of current medical monitors. Medical monitors participate as team members in clinical trials and have a key role in U.S. Food and Drug Administration-regulated research of drugs and biologics. The course describes the advice and input that medical monitors provide to sites and sponsors. It details their role in working with investigators to assess adverse events under 21 CFR 312. It also reviews the role monitors play in safety reporting to regulatory agencies and Institutional Review Boards. Lastly, the course provides learners with an overview of drug safety and pharmacovigilance.
Audience
Clinical Research Associates (CRAs), Clinical Research Coordinators, Contract Research Organizations (CROs), Drug Safety Officers, Faculty, Medical Monitors, Principal Investigators, Research Administrators, Researchers, Sponsors, Students
Meet the Author
Richard Paul, MD – Capital Health, Inc. and Drug Development Associates, LLC
Richard Paul is a licensed MD with extensive experience in drug development, drug safety, global regulatory affairs, and translational clinical research. He has held leadership positions in clinical research, regulatory and medical safety departments with pharmaceutical companies. His experience spans medical safety, medical monitoring, drug development, and regulatory strategy.
