Pharmacovigilance during the pre-approval phases: An evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines

Drug Safety

Volumn 29, Issue 8, 2006, Pages 657-673

  Hartford, Craig G ^a,b   Petchel, Kasia S ^b   Mickail, Hani ^c   Perez Gutthann, Susana ^b   McHale, Mary ^a   Grana, John M ^b   Marquez, Paula ^d  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^b PFIZER INC   (United States)

^c NOVARTIS PHARMA AG   (Switzerland)

^d Laboratorio de Atmosfera   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG APPROVAL; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EVOLUTION; HEALTH PRACTITIONER; INFORMATION DISSEMINATION; MEDICAL PRACTICE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANIMALS; CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; GUIDELINES; GUIDELINES AS TOPIC; HUMANS; INTERDISCIPLINARY COMMUNICATION; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; JAPAN; PEDIATRICS; PHARMACEUTICAL PREPARATIONS; PHARMACOEPIDEMIOLOGY; RESEARCH DESIGN; RISK MANAGEMENT; UNITED STATES; VULNERABLE POPULATIONS;

EID: 33746861906     PISSN: 01145916     EISSN: 01145916     Source Type: Journal    
DOI: 10.2165/00002018-200629080-00003     Document Type: Review

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