Guidance Document for Industry
Title | Guidance Document for Industry PDF eBook |
Author | Canada Vigilance Program |
Publisher | |
Pages | |
Release | 2009 |
Genre | Drugs |
ISBN | 9781100126821 |
Reporting Adverse Reactions to Marketed Health Products
Title | Reporting Adverse Reactions to Marketed Health Products PDF eBook |
Author | |
Publisher | |
Pages | 43 |
Release | 2018 |
Genre | Electronic books |
ISBN | 9780660019628 |
'This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products'--Scope, p. 1.
Draft Guidance Document for Industry
Title | Draft Guidance Document for Industry PDF eBook |
Author | |
Publisher | |
Pages | |
Release | 2006 |
Genre | Drugs |
ISBN | 9780662442240 |
Directives Du Programme Des Medicaments : Lignes Directrices Concernant la Notification Des Effets Indesirables Des Medicaments Commercialises
Title | Directives Du Programme Des Medicaments : Lignes Directrices Concernant la Notification Des Effets Indesirables Des Medicaments Commercialises PDF eBook |
Author | Drugs Programme (Canada) |
Publisher | Canadian Government Publishing |
Pages | 19 |
Release | 1996-01-01 |
Genre | Drugs |
ISBN | 9780660166353 |
Amendments to the Food and Drug Regulations.
Registries for Evaluating Patient Outcomes
Title | Registries for Evaluating Patient Outcomes PDF eBook |
Author | Agency for Healthcare Research and Quality/AHRQ |
Publisher | Government Printing Office |
Pages | 385 |
Release | 2014-04-01 |
Genre | Medical |
ISBN | 1587634333 |
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Dietary Supplements
Title | Dietary Supplements PDF eBook |
Author | United States. Federal Trade Commission. Bureau of Consumer Protection |
Publisher | |
Pages | 32 |
Release | 1998 |
Genre | Advertising |
ISBN |
Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Adverse Reaction Database
Title | Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Adverse Reaction Database PDF eBook |
Author | |
Publisher | |
Pages | |
Release | 2005* |
Genre | Drug interactions |
ISBN |
Includes information concerning suspected adverse reactions to Canadian marketed health products of pharmaceuticals, biologics (including blood products and therapeutic and diagnostic vaccines), natural health products, and radiopharmaceuticals, as reported to Health Canada through voluntary and mandatory reporting measures.