CHAPTER 1 Introduction to Clinical Rese Essay

Submitted By Calin-Popa
Words: 3343
Pages: 14

Module 1:
Introduction to
Clinical Research

Calin Popa, MD, CCRA
Director, Clinical Training and
Development
Advanced Clinical Research Services, Inc.

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Agenda


The Pharmaceutical and Medical Device

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
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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.


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THE PHARMACEUTICAL AND MEDICAL
DEVICE INDUSTRY

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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.


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Drug definition


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…..


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Drug Classification


By chemical properties



By the mode of administration



By the biological system affected:



By the therapeutic effects:



WHO - Anatomical Therapeutic
Chemical (ATC) Classification System

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Medical Devices definition


A product used for medical purposes in patients, in diagnosis, therapy or surgery. 

Act by means like physical, mechanical, thermal, physicochemical or chemical means.


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Included in the category: Medical

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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


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Medical Device Classification


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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…