Good Documentation Practices for Clinical Trials 2014

Topics

• Regulatory Requirements for INDs and IDEs
• Statutes, Regulations and Definitions
• Clinical Investigators (CI)
• Clinical Trials
• Sponsors and Monitors
• Institutional Review Boards (IRBs)
• ICH-GCP Guidelines
• Contract Research Organizations (CROs)
• List of SOPs and Adequate Documentation
• ISO 14155
• Common GCP Deficiencies in EU and US
• Key Elements in the SOPs
• Enforcement Actions

Who should Attend

• Regulatory Affairs
• Clinical Affairs
• R&D
• Quality Assurance
• Contractors/Subcontractors
• Consultants
• Senior Management