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| Date: | Name: | Location |
| Tuesday, March 23, 2010 9:00 AM TO 4:30 PM (Registration 8:30 AM) |
Introduction to Canadian Regulatory Affairs |
Fairfield Inn & Suites 3299 Caroga Drive Mississauga, ON 905-673-9800 Pearson Room |
| Fees: | Registration Link: | Registration Deadline |
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PSG Member:
$395.00 + $19.75GST = $414.75 Non-Member: $475.00 + $23.75GST = $498.75 |
Registration for this course is currently closed. |
Thursday, March 18, 2010 |
| Course Objective: | ||
This one day course will provide an overview of the Canadian regulatory system and requirements for prescription pharmaceuticals with a focus on the role of the regulatory professional. |
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| Course Description: | ||
This course will cover the following topics: o Canadian regulatory framework o Health Canada organization o Role of the Regulatory Affairs professional o Submission types and review cycles o Common Technical Document format o Product Monograph format and key issues o Product licensing framework |
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| Course Leader: | ||
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Janice Weiler, B.Sc. Janice Weiler is the principle consultant at Weiler Regulatory Solutions, a consulting company specializing in Canadian regulatory affairs for pharmaceuticals, biologics, natural health products and medical devices. Over her 18 year career in the industry, Janice has held positions in Drug Information, Quality Assurance, and for the last 13 years, in Regulatory Affairs. She has extensive experience with pharmaceuticals and particularly with biologics. Janice has managed all aspects of regulatory files from Clinical Trial Applications through New Drug Submissions and post market changes in a variety of therapeutic areas. Janice graduated from the University of Guelph with an Honours B.Sc. in biomedical toxicology. |
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| Who Should Attend: | ||
This one day course is intended for individuals new to Regulatory Affairs or interested in Regulatory Affairs and working in areas such as Quality, Manufacturing, Research & Development and Drug Information. |
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Health Canada/Santé Canada • U.S. Pharmacopeia (USP)
Canadian Association of Professional Regulatory Affairs/Association canadienne des professionnels en réglementation (CAPRA/ACPR)
Copyright 1999 - 2010 • National Pharmaceutical Sciences Group Inc. • All Rights Reserved