Conducting Observational Studies in US, Canada and Europe
June 8, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Overview: This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada. Some guidelines have been developed and others are in the process of being developed. In some jurisdictions clinical trials are differentiated from observational studies. Conducting such studies retrospectively or prospectively can have a different requirement from a regulatory perspective. The same study done in different jurisdictions will follow different regulatory pathways. Working through this confusing environment is very difficult. Areas Covered in the Session: What observational studies are and when they are used, including actual examples of such studies conducted in the United States, Canada and Europe. When retrospective observational studies are useful and when prospective observational studies are done. The difference between observational studies and registries. Existing guidelines on such studies in the various jurisdictions. Regulatory requirements to conduct such studies in a jurisdiction. Multi-center studies conducted across jurisdictions. When payer databases are useful and when other approaches are used. Reporting adverse events in observational studies. Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1auvreL support@compliance4all.com www.compliance4all.com