BioEntrepreneurship: Navigating the Global Regulatory Path for New Drugs January 16, 2008

The BioEntrepreneurship series is designed to be complementary to MaRS Entrepreneurship 101, which maps out the general steps related to launching a technology-based business.

These BioEntrepreneurship seminars aim to give insight specifically into the bio-industry and the elements necessary to effectively commercialize life sciences research (therapeutics, devices, diagnostics). Each lecture is taught by active industry professionals and is followed by an extensive Q&A session. Participants are encouraged to use the interactive segment of each seminar to discuss their specific projects.
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So you have a device or drug candidate and you are ready to take it into humans. Now what?

This course will cover the how-to's of the regulatory approvals process. It will include a review of the submissions required to be filed for conducting clinical trials in the US, Europe or Canada and insight into strategies that have been successful in the past and potential pitfalls to be avoided. The course will also cover marketing applications for these three regions, including a discussion of how the International Conference on Harmonization fits into the overall regulatory scheme of drug development.

Registration required.

$15 General registration
Free for students and post-docs

Official Website: http://www.marsdd.com/Events/Event-Calendar/BioEntrepreneurship/2008/regulatory-affiars-011620008.html