|
Summary: Seminar “Clinical Trial Applications in Canada, and Comparison to US and EU” explains the working of Health Canada’s clinical trials and drug development in all their details. Venue, date and timings: Anne Tomalin, President of Therapeutic Products Inc., will be the speaker at this two-day session. The venue for this seminar, which will be on March 27 and 28 (Thursday & Friday) at Toronto, Canada from 8.30 A.M to 5.30 P.M., will be announced soon. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. What the seminar is about: Conducting clinical trials is now no more an activity that a country can carry out in isolation. It has become a global undertaking. This means that if companies undertaking clinical trials have to add their respective sites to global sites; they need to have a sound understanding of the ground rules of individual countries. This seminar gives an understanding of the details of conducting such trials in Canada. The benefit of this understanding is that it will enable companies to add Canadian sites to their global trials, the direct result of which is that it opens up access of the excellent network of researchers in this North American country. This is a legitimate and reasonable point, because the FDA recognizes Canadian sites and equates them with US sites in their review of NDAs. Even within Canada, there are significant tax credits related to the conduct of clinical trials in the country. So, if Canadian researchers and drug developers need to make the best make use of these fiscal policies; the need to get a firm and clear understanding of how to conduct research in Canada. Furthermore, for Canadian companies, it is important to understand the way research is done there, as it will be a gateway for them to get a grasp of how it compares to the US and EU. The big benefit of knowing the way research is carried out in Canada is that it helps in getting funded for research. When these companies go for funding options, they will be required to clearly present the strategy for development that they are following in Canada, the US and EU. This seminar will be of immense benefit in helping participants understand these nuances. It will discuss threadbare the elements that go into Health Canada. It will cover the organization of Health Canada as it relates to: a. clinical trials and drug development; b. Canadian regulations governing the conduct of clinical trials; c. the process for getting approval of clinical trials; d. requirements after approval of the trial; e. submission of safety data; f. inspections by Health Canada related to clinical trials; g. Good Manufacturing Procedures (GMP) requirements for clinical trials; h. the conduct of Phase IV clinical trials, and i. pending changes to the conduct of clinical trials in Canada. The speaker will discuss and review requirements for drugs, biologics, gene therapy and natural health products. In addition, she will discuss the conduct of clinical trials in Canada to the conduct of such trials in the US or EU. About the Speaker: Anne Tomalin is President of Therapeutic Products Inc., which she founded in 2013. Anne is also the founder of CanReg Inc., which she founded in September 1996 and ran successfully till it was acquired by OptumInsight in December 2009. Prior to this, Anne was employed for 20 years with Searle Canada, a unit of Monsanto Canada Inc., as Business Unit Director. Prior to joining Searle, Anne was employed by Hoffmann-LA Roche Limited for three years and with Wyeth Ltd for three years. 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. Agenda This is the agenda of this seminar: Day 1 Lecture 1: Registration & Breakfast Lecture 2: Regulatory Basis for Oversight of Clinical Trials Lecture 3: Overview of Health Canada Lecture 4: Filing a CTA in Canada Lecture 5: Filing a CTA in Canada Lecture 6: Amendments to Protocols and Supplies Lecture 7: Good Clinical Practice Lecture 8: Inspections and Q & A Day 2 Lecture 1: Review of Day 1 Lecture 2: Special Considerations for Biologics Lecture 3: Special Considerations for Gene Therapy Lecture 4: Special Considerations for Use of Devices in Clinical Trials Lecture 5: Pharmacovigilance in Clinical Trials Lecture 6: Phase IV Clinical Trials Lecture 7: Research Ethics Boards Lecture 8: Clinical Trial Groups Lecture 9: Q & A and Wrap Up For whom: This seminar will benefit professionals in/among the following areas: a. Director of Regulatory Affairs b. Regulatory Affairs Managers c. Coordinator of Regulatory Affairs d. Regulatory Affairs Associate e. Clinical Research Associate f. Clinical Manager g. Director of Product Development h. Pharmacovigilance Manager for Clinical Trials i. R&D Managers and Directors About GlobalCompliancePanel: GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing/Clinical/Lab), EU and ISO. These seminars are an extension of online trainings, at which GCP has conducted around 700 webinars since inception on a variety of topics for these industries /verticals. More than 30,000 professionals have benefited from these trainings. GlobalCompliancePanel’s trainings are focused, flexible and tailored to the client’s need. This is the next in a series of regulatory and compliance related seminars that GlobalCompliancePanel has been organizing all over the US. Its previous seminars have met with resounding success. GlobalCompliancePanel’s seminars have helped participants reach their career milestones. In bringing globally renowned experts in the field of regulatory compliance and executives in the industry together, GlobalCompliancePanel fosters a learning experience. With trainings that are focused and relevant, GlobalCompliancePanel seeks to serve as a bridge in the area of continuous professional education for regulatory and compliance-related fields. Price: 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 Discounts are available for group participation in the following manner: For two attendees: 10% discount For three to six attendees: 20% discount For seven to 10 attendees: 25% discount For more than 10 attendees: 30% discount To avail the above group discounts, all the participants should register by making a single payment. Please note that the registration will be closed two days (48 hours) prior to the start date of the seminar. Call our representative on 1800 447 9407 to have your seats confirmed. Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT- http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC, 161 Mission Falls Lane Suite 216, Fremont CA 94539
Related Articles -
Iso 13485 Design, Sox Compliance Training, Design History File, compliance training, Medical Device Training, 510K Compliance Training, 510k Webinar,
|
