Clinical Trials in US, Europe and Canada
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This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.
Discussion will occur regarding the process for changing protocols or clinical trial supplies, including when prior approval of such changes are required. The approach to adverse drug reactions will be discussed. Clinical trial registries are confusing and vary from country to country. The data that must be made public and the timing of these publications has been changing the last several weeks. We will discuss what must be done when a trial is discontinued prematurely or if a regulatory agency refuses to approve your trial.
Why should you Attend: Knowing the regulatory requirements across these jurisdictions is mandatory for any company trying to conduct clinical trials across these countries. Knowing how a clinical trial is approved, how changes to clinical trials or clinical trial material needs to be submitted, how adverse reactions are handled, how clinical trials are registered and what data needs to be made public are all fundamental issues for companies entering this highly regulated area. This session will provide an overview of these topics and strengthen your knowledge so that you can move forward confidently.
Areas Covered in the Session:
Who Will Benefit:
- Regulatory requirements for Phase I-3 clinical trials to gain approval to conduct the trial
- Process for approval, when pre-IND meetings or Scientific Advice meetings are useful.
- Handling changes to protocols or clinical trial supplies.
- How adverse reactions are handled, including the development of Development Safety Update Reports.
- How registries fit into the picture.
- Data that must be made public.
- How are premature discontinuations of clinical trials handled
- Requirement if a Regulatory Agency refuses a clinical trial
- Requirement if an Ethics Board refuses a clinical trial.
- Director of Clinical Research
- Manager of Clinical Research
- Coordinator of Clinical Research
- Director of Regulatory Affairs
- Manager of Regulatory Affairs
- Manager of Medical Affairs
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.