Being one of our nearest neighbors and home to an active and ever-growing medical device manufacturing community, it made sense to invite Fabio De Pasquale of Vancouver to provide an overview of Canadian device regulations. I wanted Fabio to give this e-conference because I've noticed an increase in the number of clients who are conducting clinical trials in Canada. If you're doing more trials in Canada, my instinct tells me you may want more information.
Advantages of Canada
There are many advantages to implementing a device trial in Canada. Canada's thriving device industry promises a host of trained investigators. It costs less than European or Asian trials. Regulations are easier than the States in many respects. Investigators speak English, are trained in Western medicine, and are trained in good clinical practice. There are no excise taxes on the sale of devices, in case you're doing a post-market study.
Have a little fun
If you have done, are considering, or are planning, a clinical trial in Canada, answer the PollMonkey question to see if you are in step with your colleagues.
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Motivate Your Study Staff: Give an Adverse Event Wheel
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Canadian regulations--an overview
The presentation will begin with an overview of the Canadian Medical Devices Regulations (MDR), the Investigational Testing Authorization (ITA) provisions of the MDR, common pitfalls in obtaining approval, and privacy legislation in Canada.
Twenty questions
Integrated into his planned presentation, I've asked Fabio to address some specific issues likely to be on your minds. He'll address all of these issues, although not necessarily in this order:
[1] How are medical devices classified in Canada?
[2] Are clinical trials classified by risk, as they are in the US?
[3] What is the Special Access Programme (SAP)?
[4] What is the best website for learning about Canadian regulations?
[5] Do sponsors need approval from Health Canada/Medical Devices Bureau for ALL device trials?
[6] What is an REB (Research Ethics Board) and what is its authority?
[7] Do sponsor's need REB approval for all device trials? If not, why not, and how can I take advantage of it?
[8] How long does it take for Health Canada approval of a clinical trial?
[9] Can sponsors submit a protocol to Health Canada and the REB simultaneously, or must it be sequentially?
[10] If sequential, who gets the protocol first, Health Canada or the REB?
[11] Are sponsor's required to report ALL adverse events that occur with an investigational device to the REB, or only device related adverse effects?
[12] How about to Health Canada?
[13] Does Canada have a corollary to the US unanticipated adverse device effect?
[14] Does Health Canada have an application fee for requesting approval for a trial? How about the REBs?
[15] What are the manufacturing requirements for investigational devices?
[16] Are there special validation requirements for investigational devices using software?
[17] Some regulatory authorities require independent adjudication of adverse events to get an unbiased determination of device-relatedness; the independent opinion is issued by a Data Safety Monitoring Board. Does Health Canada ever require DSMBs?
[18] What about French translations, when do sponsors need them?
[19] How readily, to your knowledge, is Canadian data accepted by FDA?
[20] Does Canada impose an excise tax on the sale of medical devices?
Still more questions?
Now's your chance; if you have more questions about the process of initiating and conducting clinical trials in Canada, submit them to CDG. We'll make sure your questions are forwarded on to Fabio so he can address them during the presentation.
Learning objective
Our learning objective? To give you all the information you need to decide whether or not to use Canada in your next clinical trial.
You will receive
[x] PowerPoint slides.
[x] Expert and experienced speaker.
[x] Approval Flowchart for trials in Canada.
[x] Links to the regulations and guidelines.
[x] Chance for Q&A.
[x] CEUs and certificate of attendance.
Who should attend
[x] Anyone who's considering a device trial in Canada.
[x] Anyone who monitors clinical trials in Canada.
[x] Regulatory professionals who want to improve their Canadian knowledge-base.
[x] FDA personnel who review data from Canadian trials.
[x] FDA inspectors who inspect Canadian sites or sponsors.
Instructor
Fabio De Pasquale is the President of QA & RA Medical Device Consulting, Ltd. The company, based in Vancouver, BC (Canada) provides Quality Assurance, Regulatory and Clinical Affairs pre and post approval services to the medical device and diagnostics industry. His extensive knowledge and expertise of medical device regulations has helped many multinational manufacturers to bring their medical devices to the marketplace, assuring sustainable regulatory compliance.
The company specializes in Quality Assurance (QMS design, implementation and audit in compliance with QSR/GMP, ISO 13485:03, EU- MDD and Canadian MDR/CMDCAS), Regulatory Approvals (510k, PMA, 513g, Canadian MDL, CE Mark) and Clinical Studies Consulting (IDE, ITA, EU study design, management and monitoring).
Prior to working as a consultant, Fabio worked with several medical device organizations as Director of QA, Regulatory and Clinical Affairs. Fabio holds a Master’s Degree in Nuclear Engineering, a Master’s in Business Administration (MBA) and is a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at qa.ra.meddev@telus.net.
The purchase is $423 for OnDemand access and $473 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.