Presented by Richard Parcels, McCarthy Consultant Services, Inc.; Friday, March 2, 2018; 1:00pm – 2:30pm EST (GMT -5)
Canada, a significant market for drug manufacturers worldwide, is often particularly attractive to US firms. Canada is a logical destination for international expansion, with Government-funded health care, a familiar culture, proximity to the US, an educated, prosperous population, and stable government. However, bringing pharmaceuticals and health care products to the Canadian market and ensuring their continued regulatory compliance is governed by requirements that are often significantly different from those applied by the FDA.
Companies with health care products already marketed in Canada need to be aware of recent amendments to pharmaceutical legislation and how these sweeping new Health Canada initiatives are changing the regulatory landscape that biopharmaceutical companies must now negotiate.
How do Health Canada's drug regulatory requirements affect you TODAY?
On Friday, March 2 at 1:00pm EST, join FOI for a 90-minute, audio-format presentation during which Richard Parcels will offer an expert explanation of the updated Canadian regulatory process for drug approval – and, once approved, how to make sure your products can remain on the Canadian market. You'll come away with an understanding of the steps to market authorization, the common mis-steps and hurdles you can avoid, and learn the potential consequences of non-compliance.
Topics to be Addressed Include:
- The most important provisions incorporated into Health Canada’s regulation of drugs and natural health products
- Bill C-17 Updates and Implementation
- Important steps to take to successfully complete a drug and natural health product license application
- Costs for your drug and natural health product licenses and annual renewals
- Investigational testing requirements
- Your ongoing compliance obligations
What You'll Get:
- A practical summary of the Canadian drug approval process
- An overview of how your company could be affected by the most recent rules
- 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:
Richard Parcels has over twenty years of experience in the pharmaceutical, natural health product, cosmetic and medical device fields. He holds a B.Sc. in Microbiology from the University of Guelph, and has worked at Agriculture Canada, Warner-Lambert Parke-Davis, AstraZeneca, Estee Lauder and as an industry consultant across consumer health related industry for 12 years. He specializes in regulatory affairs, quality systems, training and auditing.
Richard is currently an industry consultant and Associate with McCarthy Consultant Services, Inc. He also serves as the Assistant Director of Regulatory & Scientific at Cosmetics Alliance Canada, where he works to enhance and protect the ability of member companies to conduct business effectively in Canada by fostering industry and government cooperation and by using sound science and risk-based approaches to inform and shape regulation, policy and guidance.
Richard plays a leadership role in the development of Health Canada’s new Self-Care Products Framework which seeks to modernize current regulation to provide consistent rules and the right tools to efficiently manage a broad range of low-risk products, including cosmetics and personal care products.
In your office, conference room – or anywhere else you are!
Friday, March 2, 2018; 1:00pm to 2:30pm EST (GMT -5)
You can register for any of these options below. If you have questions or prefer to register by phone, call us at +1-301-975-9400.
Standard Order...Listen Live!
Your first toll-free (even if international) dial-in is $449 and covers one telephone connection – put the teleconference on your speakerphone and let everyone present listen for one price!
FOI Services will provide handouts and dial-in information for each connection ordered 1-2 business days before the teleconference.
Add extra connections to your Standard Order for only $89/line! Now you can affordably let colleagues in scattered offices, at home, on the road, or anywhere else listen live, too! When you place your Standard Order for a teleconference at the regular $449 price, you now have the option of adding more lines to the same invoice for only $89 per connection – just follow the directions online or call us at +1-301-975-9400! (Note: To qualify for this discount, extra lines must be ordered at the same time as a Standard Order.)
Can’t attend? 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. (Please allow one week after the event date for delivery.)
Listen Live..AND get a 50% discount on the Audio Package! If you order a live registration and the Audio Package for the same teleconference, you’ll receive a 50% discount on the audio. To order both the live registration and the audio package, register below, and you will be given an opportunity to add the audio as well. Or if you prefer, you can always phone FOI at 1-800-654-1147 (outside the U.S. and Canada call +1-301-975-9400).