Industry
• Drugs
• Medical devices
• General overview of the industry
Milestones in clinical research and human rights. • Food and Drug Administration
• Heath Canada
• ICH-GCP
• Important Milestones in Research Ethics
Careers in Clinical Research
T h e
Objectives
Update the information about the
Pharmaceutical and Medical Device
Industry
Understand definitions and classification of drugs and medical devices Know regulatory bodies and where they regulate
Recognize the milestones in clinical research and human rights.
Drug definition
Generally speaking - any chemical substance that, when absorbed into the body of a living organism, alters normal body function
Pharmacology - a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being
Federal law - any substance recognized in the official pharmacopoeia or formulary of the nation.
World Health Organisation (WHO) –
any substance or mixture of substances
manufactured, sold, offered for sale, or represented for use in the diagnosis, treatment, mitigation, or prevention of disease, abnormal physical state or the symptoms thereof in humans… restoring, correcting, or modifying organic functions in humans…..
Medical Device Classification
CANADA:
Class I devices - present the lowest potential risk and do not require a licence.
Class II devices - require the manufacturer’s declaration of device safety and effectiveness
Class III and IV devices - present a greater potential risk and are subject to in-depth scrutiny. A guidance document for device classification is published by Heath Canada
Canadian classes of medical devices generally correspond to the European
Council Directive:
Class IV Class III (ECD), ex: cardiac pacemakers Class III Class II (ECD), ex: orthopaedic b implants, haemodialysis machines
Class II Class II (ECD), ex: contact lenses a Class I Class I (ECD), ex: surgical
