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PRA3005 Regulatory Affairs for Medical Devices

This course will introduce students to the field of medical devices that are not falling under the category of drugs and will define medical devices, discuss existing challenges for innovative research, medical devices classification, international and local guidelines and regulations regarding the devices’ approval and the conduct of associated clinical studies required for regulatory approval. In addition, the course will outline clinical research involving medical devices and regulations for medical devices‘ safety monitoring and safety reporting.

This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.

Online Education Registration CAD$695 +HST

PRA3005 Regulatory Affairs for Medical Devices

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Toronto Campus

885 Sheppard Avenue West Toronto, Ontario M3H 2T4, Canada

Hours of Operation

Mon-Fri 8:30am - 5:00pm Sat - by appointment only
Telephone: 416-502-2277 Toll Free: 1-855-502-2288 Email:
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