BioEntrepreneurship

Last night, an audience of almost 50 people braved the weather to attend the MaRS Bio-Entrepreneurship Series “Navigating the Global Regulatory Pathway�. The audience came from a wide range of disciplines including research, entrepreneurship, insurance and finance. The breadth of audience highlighted the relevance of this topic, as well as the complexity of understanding the regulatory requirements in Canada and abroad.

Anne Tomalin, President of CanReg Inc., shared her insights and expertise based on years of specialized experience in this field. Anne provided an overview of the Drug Development, Clinical Trials, Drug Applications and Drug Submissions Process in the Canadian, American and European markets.

Audience members asked provocative questions regarding testing stages and cross-boarder applications like beginning part of Phase III testing before all Phase II trials are complete, or applying for drug approval in the U.S. and Canada simultaneously.

Despite the amount of information provided in this comprehensive 3-hour session, I quickly learned that there are many subtleties in the regulatory environment that can be very costly if misunderstood. Each case can be quite unique, and any entrepreneur – especially one with limited financial resources – should be aware of the intricacies involved and should certainly consider seeking help from an expert to ensure the best use of money and time.

Downloads

• Anne Tomalin’s Presentation (PDF)
• Session presentation - Dial-up connection (mp4)
• Session presentation - Broadband connection (mp4)

*Please note that you will need a player such as Quicktime (free) to view the mp4 files and Acrobat (free) to view the PDF slides.

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