Clinical Trial Applications in Canada, and Comparison to the US and Europe
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This topic will cover the regulatory submission required in Canada (Clinical Trial Application) and comparison to Clinical Trial Applications in Europe and Investigational New Drug Submissions in the EU. Also covered will be the submission of documentation to Institutional Review Boards, the membership of these boards, and common findings of deficiencies for such Boards. Again, a comparison will be made to the US and EU.
The session will speak to documentation that is required for the investigator and site for Canada, and compare this to the other two jurisdictions. It will include a discussion of disbarred investigators in the US. Good Clinical Practice Regulations will be covered in the three jurisdictions, and a discussion of how ICH is recognized in terms of GCP. Also covered will be the submission of SUSARS for clinical trials and how this is done in the three jurisdictions. Finally, changes to protocols and investigational clinical trial supplies will be discussed.
Why should you Attend: Multinational trials require different regulatory approaches to trial approval from agencies, to trial approval from Institutional Review Boards and to certifications from investigators. Learn how Canada handles Clinical Trial Applications, what regulations say about Good Clinical Practice and how Health Canada inspects clinical trials for compliance with regulations.
This session will compare requirements in Canada to those in the US and Europe so that those conducting clinical trials in these jurisdictions understand the different requirements in different countries. Institutional Review Boards or Ethics Review Committees also have different rules and varying requirements for how these Boards are informed of clinical trials. The session will also review the requirements in each of these jurisdictions for publication of information regarding the clinical trial on various registries.
Areas Covered in the Session:
Who Will Benefit:
- Submission of CTAs/INDs
- Submission to IRBs
- Good Clinical Practice
- Suspected Unexpected Serious Adverse Drug Reactions
- Changes to Protocols
- Changes to Clinical Trial Supplies
- Publication of data on clinical trial registries
- Regulatory Affairs Directors/Managers/Coordinators/Associates
- Clinical Trial Managers/Coordinators
- Research and Development Managers/Directors
- Institutional Review Board members
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.