Making All Data Count: FDA Acceptance of non-US Clinical Trials 2013
12 Feb 2013
Webinar
Key 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
Past Events
Making All Data Count: FDA Acceptance of non-US Clinical Trials 2013 - 12 Feb 2013, Webinar (27889)
Making All Data Count: FDA Acceptance of non-US Clinical Trials 2026
Important
Please, check "Making All Data Count: FDA Acceptance of non-US Clinical Trials" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Healthcare, Medical laboratories, Pharma
