Making All Data Count: FDA Acceptance of non-US Clinical Trials 2013 is a webinar that covers topics such as:
- 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
Making All Data Count: FDA Acceptance of non-US Clinical Trials 2013 brings together:
- 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
