Establishing and following Good Clinical Practice (GCP) compliant with the FDA requirements 2012 is a webinar that covers topics such as:
- General information regarding GCP and clinical studies
- The applicable statutes and FDA regulations for clinical trials
- Requirements for INDs and IDEs
- The roles of clinical investigators, institutional review boards, sponsors, monitors and contract research organizations
- ISO 14155
- ICH-GCP guidelines
- Strategy "CAC-SI" method
- FDA enforcement actions
Establishing and following Good Clinical Practice (GCP) compliant with the FDA requirements 2012 brings together:
- Regulatory Affairs Managers, Directors and VPs
- Clinical Affairs Personnel (Coordinators, Monitors, Managers, Directors, and VPs)
- Quality Engineers, Managers,Directors, and VPs
- R&D Scientists, Engineers, Managers, Directors, and VPs
- Complaint Handling and Risk Management Managers and Directors
- Compliance Officers and Legal Counsel
- Consultants
- Clinical investigators and CRO employees
- Senior and Executive Management Anyone involved in the clinical trials or studies