Early communication of drug safety concerns: A feasibility study on enhancing interaction between the pharmaceutical industry and regulators

Pharmacoepidemiology and Drug Safety

Volumn 19, Issue 3, 2010, Pages 232-237

  Swain, Elizabeth ^a   Morgan, Sarah ^b   Brewster, Wendy ^a   Kauser, Shahin ^b  

^a GLAXOSMITHKLINE   (United Kingdom)

^b MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

Communication; Pharmaceutical safety signalling; Pharmacovigilance; Potential safety concern; Regulator; Signal; Timeframes

Indexed keywords

ARTICLE; COST BENEFIT ANALYSIS; DECISION MAKING; DRUG INDUSTRY; DRUG INFORMATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEASIBILITY STUDY; HEALTH PRACTITIONER; HUMAN; INTERPERSONAL COMMUNICATION; PILOT STUDY; PRIORITY JOURNAL; PUBLIC HEALTH;

COMMUNICATION; DECISION MAKING; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; EUROPE; FEASIBILITY STUDIES; GOVERNMENT AGENCIES; HUMANS; PHARMACEUTICAL PREPARATIONS; PILOT PROJECTS;

EID: 77649213144     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1898     Document Type: Article

References (2)

1. Article 23, [Directive 2001/83/EC].
2. MISG Report 276498 1p 0.5k Feb 07 (WP). Produced by COI for the Department of Health.