Ask Us Anything: A Panel Discussion on Navigating Medical Devices in Canada

Speakers

Moderator: Shirley Furesz, Ph.D., RAC – Director, Regulatory Affairs, Medical Devices, Cencora – Innomar Strategies

Shirley Furesz is the Director of Regulatory Affairs, Medical Devices at Innomar Strategies Inc. She has been working as a regulatory affairs consultant since 2006 and has extensive experience with medical devices, in vitro diagnostics, companion diagnostics and combination products including those used in orthopedics, cardiology, gastroenterology, general surgery, dermatology, gynecology, imaging, respiratory, ENT, urology, wound care, dentistry, infection control, and oncology.

Shirley received her Ph.D. in the area of vaccine development from the Department of Veterinary Immunology and Microbiology at the University of Guelph.  She provides regulatory strategy and manages a wide range of device submissions for Health Canada and other regulatory agencies. Shirley achieved her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society in 2009.  Prior to joining Innomar Strategies, she was a key member of the medical devices consulting team at Icon plc (previously Mapi Life Sciences, OptumInsight and CanReg Inc.) and has held various research positions at Syn-X Pharma and NoAb BioDiscoveries Inc. in the areas of Point of Care Diagnostic Kit development, Proteomics, Cell Biology, and ADME-Tox testing.

Panelist: Rami El-Sayegh – Manager, Market Access & Pricing, Cencora – Innomar Strategies

Rami is a Manager of Market Access and Pricing at Innomar Strategies. He has held various positions at Johnson & Johnson, Medical Devices, CADTH, the Canadian Institute for Health Information (CIHI), and the Federal Government of Canada. He leads many of the PMPRB pricing analyses for rare disease clients, given his expertise in the PMPRB guidelines and their methodology, and also leads reimbursement strategy projects for medical devices.

Rami has demonstrated experience in leading market access strategies to support reimbursement for drugs and medical devices, as well as extensive knowledge of the HTA submission process. He has co-authored several peer-reviewed publications and abstracts and presented at scientific conferences on health economics and clinical epidemiology.
Rami has over five years of experience working in the private and public sectors. He is a former Associate at Depuy Synthes, Johnson & Johnson, Medical Devices, providing support to health economics, real-world evidence, and reimbursement projects for the Global Orthopedics portfolio.

Panelist: Cathie Rutt, CQA, RAC – Director, Quality Assurance, Cencora – Innomar Strategies

Cathie is a Director of Quality Assurance at Innomar Strategies. Her career has included over thirty years of consulting work in pharmaceutical and medical device quality, with long experience in Good Manufacturing Practices, ISO 13485 and ISO 9001. Cathie is RAC certified and holds a current Certified Quality Auditor designation from ASQ. With a background that includes sterile drug and API manufacturing, as well as medical device manufacturing, she has been active assisting medical device clients with quality system development, implementation and maintenance, Internal Audits and Supplier Audits.

Prior to joining Innomar Strategies, Cathie was a key member of the medical devices consulting team at Icon plc (previously Mapi Life Sciences, OptumInsight and CanReg Inc.), and has held various quality systems positions at Brantford Chemical and Novocol Pharmaceutical.

Panelist: Raje Devanathan BSc, MSc, Cert.RAP – Senior Manager, Regulatory Affairs, Medical Devices, Cencora – Innomar Strategies

Raje Devanathan is a Senior Manager of Regulatory Affairs at Innomar Strategies. Raje has over twenty years of professional/consulting experience. She is a certified regulatory affairs professional and clinical research for medical devices. She started her career in Biologics drug research, and regulatory, extending to medical device expertise. She has worked with regulatory authorities across Europe, North America, UK, Australia, and Asia. Her extensive device experience covers medical devices, in vitro diagnostics, companion diagnostics, combination products, SaMD, wearables, medical app, 3D printing and AL/ML Devices. She is a certified ISO 13485 lead auditor. 
 
Prior to joining Innomar Strategies, she headed up the consulting and clinical team at Be-on-Quality- Germany, and other consulting businesses in UK, Ireland, North America.  She works with clients in providing Regulatory strategies and Intelligence, enabling hassle-free regulatory pathways for global markets.