Establishing and following Good Clinical Practice (GCP) compliant with the FDA requirements 2012

Key Topics

• 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

Who should Attend

• 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