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Hilton Lac-Leamy

2019 年 11 月 05 日 7:30 上午 - 2019 年 11 月 06 日 3:15 下午

3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada

DIA Annual Canadian Meeting

Session 5: Plenary Session: Innovation of Medical Devices: Challenges to Scale Up but With Opportunities to Grab

Session Chair(s)

Rania  Mouchantaf, PhD

Rania Mouchantaf, PhD

A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD

Health Canada, Canada

The last eighteen months were very dynamic for devices in Canada, Europe, US, and worldwide. This session will present what has been seen to date and will consider what may be yet to come as we explore both the challenges and opportunities in the area of medical device regulation. Various perspectives will be shared which will include regulatory, industry, and the patient. In turn, the session will provide attendees with an understanding of the recent activities surrounding medical devices in Canada including updates to the regulations as they pertain to medical device classification and the corresponding regulatory requirements and pathways to market authorization.

Learning Objective : At the conclusion of the session, the participants:
  • Understand the current and future directions as they relate to medical device regulations in Canada
  • Recongize the role of patient engagement in supporting regulatory decisions for medical devices

Speaker(s)

David  Boudreau

Challenges and Opportunities in Premarket Evaluation of Medical Devices

David Boudreau

Health Canada, Canada

Director General, Medical Devices Directorate, Health Products and Food Branch

Diana  Johnson

Innovation and Regulation: Challenges and Opportunities

Diana Johnson

Medtech Canada, Canada

VP Regulatory Affairs

Kimberley  Hanson, MBA

Patient Needs and Demands for Medical Devices

Kimberley Hanson, MBA

Diabetes Canada, Canada

Executive Director, Federal Affairs

Patrick  Fandja, MBA, MS

Panelist

Patrick Fandja, MBA, MS

Health Canada, Canada

Director, Bureau of Biologics, Radiopharmaceuticals and Self-care products

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