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Overview: This seminar will cover the organization of Health Canada as it relates to clinical trials and drug development, Canadian regulations governing the conduct of clinical trials in this country, the process for getting approval of clinical trials, requirements after approval of the trial, submission of safety data, inspections by Health Canada related to clinical trials, Good Manufacturing Procedures (GMP) requirements for clinical trials, the conduct of Phase IV clinical trials, and pending changes to the conduct of clinical trials in Canada. We will review requirements for drugs, biologics, gene therapy and natural health products. In addition, we will discuss the conduct of clinical trials in Canada to the conduct of such trials in the US or EU. Why you should attend: Conducting clinical trials is a global undertaking. Understanding the details of conducting such trials in Canada will enable companies to add Canadian sites to their global trials, and access the excellent network of researchers in this country. The FDA recognizes Canadian sites as US sites in their review of NDAs. Within Canada there are significant tax credits related to the conduct of clinical trials in this country. Canadian researchers and drug developers can best make use of these fiscal policies by understanding clearly how to conduct research in Canada. For Canadian companies it is important to understand how research is done in this country and how it compares to the US and EU. Raising money to fund research will require that you present clearly the strategy for development that you are following in Canada, the US and EU. Course Outline: Day One: • Agenda Content • Registration & Breakfast • Regulatory Basis for Oversight of Clinical Trials • Overview of Health Canada • Filing a CTA in Canada • Coffee break • Filing a CTA in Canada • Amendments to Protocols and Supplies • Lunch break • Good Clinical Practice • Coffee break • Inspections and Q & A Day Two • Review of Day 1 • Special Considerations for Biologics • Coffee break • Special Considerations for Gene Therapy • Special Considerations for Use of Devices in Clinical Trials • Lunch break • Pharmacovigilance in Clinical Trials • Phase IV Clinical Trials • Coffee break • Research Ethics Boards • Clinical Trial Groups • Q & A and Wrap Up Who Will Benefit: • Director of Regulatory Affairs • Regulatory Affairs Managers • Coordinator of Regulatory Affairs • Regulatory Affairs Associate • Clinical Research Associate • Clinical Manager • Director of Product Development • Pharmacovigilance Manager for Clinical Trials • R&D Managers and Directors About Speaker: 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. Date, Venue & Price: Location: Toronto, Canada 27th & 28th March 2014 8:30 AM to 5:30 PM Venue: Courtyard Toronto Downtown Price: $1,395.00 Register now and save $200. (Early Bird) Until February 15, Early Bird Price: $1,395.00 from February 16 to March 25, Regular Price: $1,595.00 Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Event Link - http://bit.ly/1hpM3Tm LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane,Suite 216, Fremont, CA 94539, USA
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