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Regulatory Strategy for Medical Devices

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Location

Sunnybrook Health Sciences Centre

2075 Bayview Avenue

Lecture Theatre M6-502

Toronto, ON M4N 3M5

Canada

Event description

Description

Execution of a sound regulatory strategy is paramount to the successful development and commercialization of a medical device. The regulatory requirements that drive strategies are predicated on risk-based device classification schemes.

The lecture component of this session will provide participants with an understanding of the medical device regulations, in key markets, as they pertain to medical device classification and the corresponding regulatory requirements and pathways to market authorization. Real-world examples will be discussed, demonstrating the processes to classify various devices in Canada, United States and the European Union. An overview of regulatory strategy development will be provided along with a tool kit to assist entrepreneurs to compile the critical regulatory and market information that informs the decision of initial target market for their proposed product.

The workshop component will provide participants with an opportunity to practice classification of a medical device (tangible or fictitious – examples will be provided) in international jurisdictions, and to explore the available resources to inform a regulatory strategy. Exercises will employ tools and templates that will be provided to participants for use during the sessions and for future reference.

Learning Objectives

1) Understand the impact of risk-based medical device classification on regulatory requirements

2) Apply tools and resources to appropriately classify a medical device in key regulatory jurisdictions

3) Recognize the critical elements of a regulatory strategy

4) Understand the processes and data sources for developing a regulatory strategy




Agenda

17:00 Introduction to Medical Device Regulations

17:10 Medical Device Classification in Key Markets

17:25 Market Authorization Pathways by Classification

17:40 Regulatory Strategy Development

17:55 Q&A

18:00-18:30: Break and Networking Mixer (Light dinner will be served)

18:30-19:45: Workshop

19:45-20:00: Summary & Discussion




Guest Speaker: Frank Shannon


Frank Shannon is the Vice President, Clinical Research, Regulatory and Quality Affairs at Interface Biologics Inc. He has 25 years of international experience in clinical development, regulatory affairs and quality assurance and health economics in the pharmaceutical and medical device industries. Frank has led the design, execution, analysis, and reporting of numerous clinical trials and outcomes research studies with industry, government and NGO sponsors.

Frank has worked for large and medium pharmaceutical companies including Ciba-Geigy, Genentech, Roche and Boehringer Ingelheim where he led Medical Affairs for cardiovascular and cerebrovascular disease areas in Canada, as well as late phase clinical development projects, globally. Subsequently, he moved to the medical device sector, joining Occulogix as the Director of Clinical and Outcomes Research. More recently, he held executive positions in Regulatory Affairs and Quality Assurance at St. Jude Medical and Baxter Corporation, in Canada.

Following his bachelor’s degree in Psychology at Brock University, Frank undertook graduate studies in Epidemiology at the University of Toronto and the Institute for Clinical Evaluative Sciences.

Outside of work, Frank enjoys spending time in the woods or on the water – camping, hiking and canoeing with his wife, son and twin daughters.





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Date and Time

Location

Sunnybrook Health Sciences Centre

2075 Bayview Avenue

Lecture Theatre M6-502

Toronto, ON M4N 3M5

Canada

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