Overview: This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada. 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.

Date : 8th June 2015 to 8th June 2015

Place : United States, Fremont

Website :http://bit.ly/1auvreL

Contact Person:Adam Fleaming

Description:

Overview: This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada. 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.

Overview: This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada. 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. will be held in Fremont,United States on date 2015-06-08

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Deadline for abstracts/proposals : 7th June 2015

Keynote Speakers :

Check the event website for more details.