Health Canada Regulatory Insights audienceThe Health Canada Regulatory Insights Workshop 2019 was held on November 15, 2019 and was attended by 120+ researchers, industry professionals and students. Hosted by the Centre for Bioengineering and Biotechnology, this unique event was in response to a pressing need for clarity and information regarding Health Canada regulatory processes and evaluations. The event featured two guest speakers from Health Canada, a panel moderated by CBB member George Shaker, and networking opportunities with leading health industry professionals.

Special guest speakers and panel participants from Health Canada:

Colin Foster, Manager, Device Licensing Services Division, Health Canada | Gestionnaire Division des services d’homologation des matériaux Bureau des matériels médicaux,  Santé Canada

Colin’s academic background is in the area of cellular and molecular medicine with a specific focus on cancer-based retinoid therapies (M.Sc). Colin has been a medical device regulator with Health Canada for 10 years and is currently the manager of the Device Licensing Division. Colin and his team are responsible for helping stakeholders understand their regulatory obligations. As part of these responsibilities, Colin’s group helps manufacturers categorize their devices according to Health Canada’s risk classification system and advises them on how to register their devices to obtain market authorization. Colin also contributes to the development of policies, guidance documents and tools that help establish a more transparent and efficient regulatory system in Canada.

[View Colin's presentation slides]

Patrick Assouad, Senior Scientific Evaluator, Digital Health, Device Evaluation Division at Health Canada | Division de la santé numérique, Bureau des matériels médicaux, Santé Canada

Patrick Assouad has been working with the Medical Devices Bureau at Health Canada for the past 8 years. His academic background includes degrees in physics, space sciences, and medical physics. He has worked at the Canadian Space Agency on shuttle missions and the International Space Station program for several years. He then spent several years in R&D of satellite imaging technologies focussing mostly on hyperspectral imaging sensors. This experience was later transferred into the medical field with work on the development of photonic-based medical devices. Patrick has participated in the activities of the Medical Devices Bureau since 2011 as a scientific evaluator. His area of expertise includes digital health technologies as well as radiation emitting devices such as linear accelerators, X-ray and CT devices, and medical lasers. Patrick joined the Digital Health group within MDB when it was first created and is actively participating in developing Canada’s stance on the use of digital technologies, including cybersecurity and AI, for health applications.

[View Patrick's presentation slides]

Panel Moderator:

George Shaker 

Professor George Shaker is an adjunct assistant professor at the Department of Mechanical and Mechatronics Engineering as well as the Department of Electrical and Computer Engineering at University of Waterloo. He also oversees wireless activities in the sensors and devices lab at the UW-Schlegel Research Institute for Aging. Previously, he was with Research in Motion (BlackBerry). He was also with Georgia Institute of Technology.

George has authored/coauthored 90+ publications and 20+ patents/patent applications. He has received – along with his research students – more than 50 international awards and recognitions. Over the last few years, George has contributed to launching numerous wireless and wearable devices to the market, whether with startups or larger organizations.  

Panel member:

Deborah Pinchev

Deborah is the Toronto QA/RA Manager at StarFish Medical, Canada’s largest medical device development company. Deborah has 5 years of Regulatory and Quality experience with a focus on the medical device industry. Prior to joining StarFish, she was a Laboratory Manager for a cell biology research lab at Mount Sinai Hospital in Toronto. Deborah earned her B.Sc. in Biochemistry at the University of Guelph, her M.Sc. in Biochemistry and Biomedical Sciences at McMaster University, and has a graduate certificate in Regulatory Affairs at Humber College.

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Special thanks to our sponsors:

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