Conducting Observational Studies in US, Canada and Europe
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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:
Who Will Benefit:
- 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.
- Director of Regulatory Affairs
- Manager of Regulatory Affairs
- Director of Clinical Affairs
- Manager of Clinical Affairs
- Coordinator of Medical Affairs
- Medical Director
- Director of Marketing
- Marketing Manager
- Reimbursement Director
- Reimbursement Manager
- Director of Epidemiology
- Manager of Epidemiology
- General Manager
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.
Anne founded CanReg Inc. in September 1996. CanReg was acquired by OptumInsight in December 2009. Prior to founding CanReg, Anne was employed for 20 years with Searle Canada, A Unit of Monsanto Canada Inc. as Business Unit Director. Responsibilities in the last several years at Searle included regulatory affairs, provincial government, reimbursement strategies, managed care, customer interface, legal and information services. Prior to joining Searle, Anne was employed by Hoffmann-LaRoche Limited for three years.
Prior to Roche, Anne was employed for three years by Wyeth Ltd. Anne has participated in the Regulatory Initiatives Advisory Committee for the Pharmaceutical Manufacturers Association of Canada (PMAC). She has also served on the executive of the Pharmaceutical Sciences Group (PSG) and the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA).
In Canada, Anne has also chaired the Manitoba, Saskatchewan and Ontario Committees for the Pharmaceutical Manufacturers Association of Canada (PMAC), now Rx&D, and she has worked with the Nova Scotia Department of Health to revamp their drug formulary. Anne is also engaged in teaching several regulatory courses to industry, including inhouse training courses for several large companies.