Description
The Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals program is designed for regulatory affairs specialists, managers, directors, and project managers. The program may also be of value to clinical research associates and clinical research coordinators with desire to grow their career into these regulatory affairs positions.
The program describes data capture and management, study design, statistical elements, endpoints, clinical trial preparation, protocol design, and clinical trials in drug development. Additionally, the program details the regarding codes, regulations, and how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials are outlined.
Courses included with this program are the following: 1) GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA – Investigational New Drug (IND); 2) Clinical Trials and Drug Development; 3) Clinical Trial Preparation and Design; 4) ICH Good Clinical Practice (ICH: GCP); and, 5) How to Obtain Approval to Conduct Clinical Trials in the EU.
