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[Administrative organization and responsibility].

https://arctichealth.org/en/permalink/ahliterature185287
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1641-2
Publication Type
Article
Date
Apr-14-2003
Author
Jannik C Hilsted
Kim Krogsgaard
Author Affiliation
Hospitalsdirektionen, H:S Rigshospitalet, DK-2100 København ø.
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1641-2
Date
Apr-14-2003
Language
Danish
Publication Type
Article
Keywords
Clinical Trials as Topic - economics - legislation & jurisprudence
Denmark
Drug Industry - economics - legislation & jurisprudence - organization & administration
Ethics Committees, Clinical
Hospital Administration
Humans
Physician's Role
Abstract
The paper describes the current organisation of clinical trials in Danish hospitals, with particular emphasis on the relationship between hospitals and the pharmaceutical industry. Legal responsibilities as well as mutual agreements on collaboration and organisation are described and discussed.
PubMed ID
12756816 View in PubMed
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Source
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S3-10
Publication Type
Article
Date
Mar-2007
Author
L. Kelly
M. Lazzaro
C. Petersen
Author Affiliation
CNSD, BCANS, Therapeutic Products Directorate, Tunney's Pasture, Ottawa, ON, Canada.
Source
Can J Neurol Sci. 2007 Mar;34 Suppl 1:S3-10
Date
Mar-2007
Language
English
Publication Type
Article
Keywords
Canada
Clinical Trials as Topic - legislation & jurisprudence - standards
Dementia - drug therapy
Drug Approval - legislation & jurisprudence - organization & administration
Drug Evaluation - legislation & jurisprudence - trends
Drug Industry - economics - legislation & jurisprudence - trends
Drug-Related Side Effects and Adverse Reactions
Humans
Meta-Analysis as Topic
Risk assessment
Abstract
The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues.
PubMed ID
17469674 View in PubMed
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Canadian media say DTC pharma ads the right Rx.

https://arctichealth.org/en/permalink/ahliterature183305
Source
CMAJ. 2003 Oct 14;169(8):822
Publication Type
Article
Date
Oct-14-2003

Distressing news on the Therapeutics Initiative.

https://arctichealth.org/en/permalink/ahliterature156161
Source
CMAJ. 2008 Jul 15;179(2):164
Publication Type
Article
Date
Jul-15-2008

Drug importation and safety of drugs obtained from Canada.

https://arctichealth.org/en/permalink/ahliterature162911
Source
Ann Pharmacother. 2007 Jul;41(7):1288-91
Publication Type
Article
Date
Jul-2007
Author
Marv Shepherd
Author Affiliation
Center for Pharmacoeconomic Studies, College of Pharmacy, University of Texas, Austin, TX 78712, USA. marvshepherd@mail.utexas.edu
Source
Ann Pharmacother. 2007 Jul;41(7):1288-91
Date
Jul-2007
Language
English
Publication Type
Article
Keywords
Canada
Drug Costs - legislation & jurisprudence
Drug Industry - economics - legislation & jurisprudence
Drug Prescriptions - economics
Drugs, Generic - adverse effects - economics
Humans
Legislation, Drug - economics
United States
Abstract
Drug importation from Canada has been hotly debated for nearly a decade. Many believe that drug importation will bring needed competition and lower US drug prices. Opposition argues that the costs of ensuring product quality and safety, as well as added healthcare costs, will offset savings attained from imported pharmaceuticals. The US needs to become innovative and seek solutions that will provide effective, safe, and economical pharmaceuticals without placing a burden on other countries and without damaging the pharmaceutical research.
Notes
Comment On: Ann Pharmacother. 2007 Jul;41(7):1111-517595307
PubMed ID
17578879 View in PubMed
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22 records – page 1 of 3.