Clinical Trial Applications in Canada and Comparison to the US and Europe
Overview: 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
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
Who Will Benefit:
Regulatory Affairs Directors/Managers/Coordinators/Associates
Clinical Trial Managers/Coordinators
Research and Development Managers/Directors
Institutional Review Board members
Anne Tomalin Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs. Anne also 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.
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Event Link - http://bit.ly/19BmRHw
Learn More: Clinical Trial Applications in Canada and Comparison to the US and Europe