The New ICH GCP E6 R2 Addendum

Topics

• Sponsor oversight requirements
• More efficient approaches to the design of clinical trials
• Risk-based approaches for setting up clinical trials
• New methodologies and technologies used in clinical trials
• Quality by design
• Risk-based management
• Risk-based monitoring including centralized monitoring
• Quality systems in clinical trials and clinical studies
• Monitoring plans
• Additional considerations for CRO management
• Risk identification, management and control
• Quality systems – including critical process and data identification
• Electronic document management – the Electronic Trial Master File (TMF)

Who should Attend

• Regulatory Affairs
• Clinical Research/Clinical Operations
• Vendor/CRO companies
• Quality Assurance (GCP Auditors)
• Pharmacovigilance
• Regulatory Authorities and Study Sites including Investigator initiated studies involved in clinical trials
• Document Management
• Clinical Trial Supply
• IT
• Legal