EU's new pharmacovigilance legislation: Considerations for biosimilars

Drug Safety

Volumn 37, Issue 1, 2014, Pages 9-18

  Calvo, Begoña ^a   Zuñiga, Leyre ^a  

^a UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; MONOCLONAL ANTIBODY; PLANT MEDICINAL PRODUCT; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN;

ARTICLE; DRUG EFFICACY; DRUG INFORMATION; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; GOOD CLINICAL PRACTICE; GOOD PHARMACOVIGILANCE PRACTICE; HEALTH CARE ORGANIZATION; HEALTH CARE PLANNING; HUMAN; IMMUNOGENICITY; MEDICINE; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; QUALITY CONTROL; RISK BENEFIT ANALYSIS; RISK FACTOR; RISK MANAGEMENT; RISK MANAGEMENT PLAN; RISK REDUCTION;

BIOLOGICAL PRODUCTS; BIOSIMILAR PHARMACEUTICALS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; PHARMACOVIGILANCE; RISK ASSESSMENT; RISK MANAGEMENT;

EID: 84896860472     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-013-0121-z     Document Type: Article

References (19)

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