7th Clinical Trials Inspection Readiness Summit

Topics

• The success of your clinical trial using metrics that measure the performance of CROs and trial sites
• Crucial information and analyze regulations from around the world, with a focus on FDA, EMA, PMDA and MHRA regulations
• Process maps that can be applied to streamline TMF management and the key team members who need to be involved
• Strategies for ensuring there is a comprehensive clinical trial storyboard so inspectors can recreate the trial

Who should Attend

• Clinical Operations
• Quality Assurance/Quality Control/Quality Compliance/Quality Management
• Clinical Trials Management
• Records/Data Management
• TMF/eTMF
• Global Compliance
• Clinical Research
• Clinical Monitoring
• Auditing
• Safety and Risk Management/Operations
• Trial Master Files
• Clinical Project Management
• Clinical Document Coordination
• Clinical Development
• Global Regulatory Affairs
• Clinical Site Management