Lecture 2 And 3

Question 1

Health Canada

Answer 1

Federal institution responsible for improving and maintaining health of Canadians. Ensuns accessible high quality healthservices and reduce health risks

Question 2

Health Canada Objectives

Answer 2

Prevent and reduce risks to individual health and environmental health, promote healthier lifestyle, ensure high quality and efficient health care services, integrate long term plans for prevention, health promotion and protection, reduce health inequalities, provide health info to public

Question 3

Health Canada Core roles (5)

Answer 3

Leader partner, funder, service provider, info provider, guardian/regulator

Question 4

HPFB

Answer 4

Health product and food branch, minimize risk and promote safety in health products and food for Canadian market, provide info to Canadians

Question 5

PDD

Answer 5

Pharmaceutical drugs directorate, approves drugs for human use in Canada. manufacturers must submit scientific proof of drug efficacy, safety and quality in accordance to the Food and Drugs Act and its regulations to be authorized for market

Question 6

Definition: Act

Answer 6

Statutory plan passed by parliament, congress or other legislative body that provides a framework for a regulatory scheme and authorizes bodies to create regulations. Called a bil, until it is approved by law

Question 7

Definition: Regulation

Answer 7

A law that provides more detail on a part of the associated Act. Not made by parliament but by a government branch such as a ministry. Apply generally and not specific to any person or situation

Question 8

Definition: Guideline

Answer 8

Departmental policy that provides standards based on the act and its regulations. Not legally binding but are required if the act and its regulations are too broad

Question 9

Defintion: drug

Answer 9

Any substance or mixture of substances manufactured, sold or represented for use in diagnosis, treatment,prevention of disease, disorder, physical abnormalities and their symptoms in humans or animals. Restoring or correcting organic functions. Disinfection in food manufacturing, storage and preparation areas

Question 10

Defintion: device

Answer 10

Any instrument, apparatus, or in vitro reagent and any of their parts por components for use in humans or animals. diagnosis of pregnancy. Care of pregnant person or animal or offspring. Contraception prevention

Question 11

Definition: clinical trial

Answer 11

Investigation of drug for use in humans involving human subjects . Discover or verify the clinical.
, pharmacological or pharmacodynamic effects and advese reactions. Study metabolism, absorption and excretion or drug and its overall safety and efficacy for use in humans

Question 12

Def5: qualified investigator

Answer 12

Individual responsible to the sponsor for conduct of clinical trial at clinical trial site. Responsible for medical care at trial site. Must be a physician or dentist in good standing with medical or dental association

Question 13

Defintion: Sponsor

Answer 13

Individual, Corporation organization or institution responsible for the conduct of a clinical trial.

Question 14

Definition investigators brochure

Answer 14

Document that contains all the Preclinical and clinical information of a drug in the clinical trial

Question 15

Protocol Definition

Answer 15

Document describing the objectives design methodology and statistical considerations of A critical trial

Question 16

Definition Research ethics board

Answer 16

Body not Not affiliated with the sponsor Approves the initiation of the trial and conducts periodic reviews of biological Research involving human participants. Protect The right safety and well being of participants Has at least five members two of which are scientific backgrounds One non scientific background one background in ethics one background in Canadian laws Must all be canadian citizens Both men and women