Making All Data Count: FDA Acceptance of non-US Clinical Trials 2013

Topics

• Types of clinical trials with regards to product development and marketing approval
• Comparison of US and non-US regulatory requirements for clinical trials
• Acceptable design of non-US clinical trials
• Parameters of quality of clinical trials: investigators and sites
• Acceptable data collection, analysis, monitoring, and documentation practices
• Acceptable ethical and human subject protection practices
• FDA’s opinion of non-US regulatory review and approval of clinical trials
• Role of IRBs, ethics committees and other regulatory bodies in clinical trial quality control
• FDA audits of non-US clinical sites
• FDA’s international clinical trial initiatives
• Waiver and other options for non-IND clinical trial data
• Best practices for using non-US human experience with products marketed outside US

Who should Attend

• Clinical trial professionals
• Compliance/Regulatory affairs professionals
• Project Managers for clinical trials
• Sponsors and investigator-sponsors of clinical trials that use non-US sites
• People investing in FDA-regulated product development projects
• Senior management for companies interested in non-US trials