Presented by Taniya Mann, PhD, MBA, McCarthy Consultant Services on Thursday, June 30, 2016
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Canada, a significant market for drug manufacturers worldwide, is often particularly attractive to US firms. Government-funded health care, a familiar culture, proximity to the US, an educated, prosperous population, stable government and similar factors contribute to making Canada a logical target for international expansion. But introducing and keeping drugs on the Canadian market has different requirements than those used at the FDA. Even those firms with products already in Canada must be aware of how recent amendments to pharmaceutical legislation and sweeping new Health Canada initiatives are now changing the landscape biopharmaceutical companies must negotiate.
How do Health Canada's drug regulatory requirements affect you TODAY?
In June, FOI hosted a 90-minute, audio-format presentation during which Dr. Taniya Mann offered an expert explanation of the updated Canadian regulatory process for drug approval – and, once approved, how to keep your products on the market. You can still hear the presentation - you'll come away with an understanding of the steps to market authorization, the common misunderstandings you can avoid, and learn the potential consequences of non-compliance.
Topics Addressed Include:
- The most important provisions incorporated into Health Canada’s regulation of drugs and natural health products…and how the updated laws are changing company responsibilities
- Important steps to take to successfully complete a drug license application
- Costs for your drug license and annual renewal – and how Health Canada arrives at the prices for your drug
- How non-compliance with current legislation can lead to fines of up to C$5,000,000 each day
- Investigational testing requirements
- Your ongoing compliance obligations
- Reimbursement programs & the role of the provinces
What You'll Get:
- A practical summary of the Canadian drug approval process
- An understanding of how your company is affected by the most recent rules
- A basis for helping you determine if you should introduce your product onto the Canadian market
- Resources for the requirements for maintaining compliance of marketed products
- An experienced and approachable instructor
- Time for questions and answers
Who Should Attend:
- Regulatory affairs professionals
- Quality assurance/quality control
- Product registration personnel
- Project managers
- Compliance personnel
- Business development professionals
About Your Instructor:
Taniya Mann, PhD, MBA began her career in pharmaceutical regulatory and governmental affairs in the early 2000s as a Senior Regulatory Affairs Manager with the Canadian arm of an international pharmaceutical firm. She quickly progressed through increasingly responsible roles, ultimately serving as Director of Regulatory and Governmental Affairs position with a major health product company. This background gives Taniya extensive experience in preparing and filing successful drug submissions with Health Canada, developing effective regulatory strategy, and managing interactions with regulatory authorities to smooth pre- and post- licensing activities. Taniya now shares her expertise with biopharmaceutical firms as an Associate with McCarthy Consulting Services, Inc. (MCSI), where she helps drug companies of all sizes and backgrounds navigate the complexities of Canadian regulatory requirements.
If you have questions about the content and coverage of this presentation, you are invited to contact MCSI directly at firstname.lastname@example.org. For more information about MCSI, a respected Canadian regulatory consulting dedicated to helping drug and device firms worldwide, visit the company’s website at www.mccarthyconsultant.com.
In your office, conference room – or anywhere else you are!
Get the MP3 & Slides:
Try the Audio Package for $449. The package includes online delivery of an mp3 file of the entire presentation, including the question and answer session, as well as all of the handouts.