How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices 2012 is a webinar that covers topics such as:
- Systematic and integrative (SI) analysis of regulations and law governing clinical trials and studies, requirements, and compliance
- Current, accurate, and complete (CAC) review of FDA regulations including INDs and IDEs
- Clinical investigators (CI)
- General information for clinical studies
- Sponsors
- Institutional review boards (IRBs)
- Contract research organizations (CROs)
- Monitors
- ISO 14155
- ICH-GCP guidelines
- Enforcement actions (case studies)
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices 2012 brings together global medical industry including those working on biologics, drugs, in vitro diagnostic devices and medical devices, who are involved in the processes of adverse event reporting, clinical trials and studies, regulatory compliance and complaint handling.
