Conducting Observational Studies in US, Canada and Europe
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.
Who Will Benefit:
Director of Regulatory Affairs
Manager of Regulatory Affairs
Director of Clinical Affairs
Manager of Clinical Affairs
Coordinator of Medical Affairs
Director of Marketing
Director of Epidemiology
Manager of Epidemiology
Anne Tomalin has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies. Anne is a graduate of York University, and holds a B.A. degree in English (1970) and a B.Sc. degree in Chemistry (1980). Anne has received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for US Regulatory Affairs (1997), European Regulatory Affairs (2001) and Canadian Regulatory Affairs (2005). Anne founded Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs.
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