A global regulatory science agenda for vaccines

Vaccine

Volumn 31, Issue SUPPL2, 2013, Pages

  Elmgren, Lindsay ^a   Li, Xuguang ^a   Wilson, Carolyn ^b   Ball, Robert ^b   Wang, Junzhi ^c   Cichutek, Klaus ^d   Pfleiderer, Michael ^d   Kato, Atsushi ^e   Cavaleri, Marco ^f   Southern, James ^g   Jivapaisarnpong, Teeranart ^h   Minor, Philip ⁱ   Griffiths, Elwyn ^g   Sohn, Yeowon ^j   Wood, David ^k  

^a HEALTH CANADA   (Canada)

^b CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^c NATIONAL INSTITUTES FOR FOOD AND DRUG CONTROL   (China)

^d PAUL EHRLICH INSTITUT   (Germany)

^e NATIONAL INSTITUTE OF INFECTIOUS DISEASES   (Japan)

^f EUROPEAN MEDICINES AGENCY   (United Kingdom)

^g Ministry of Public Health ^*

^h MINISTRY OF PUBLIC HEALTH   (Thailand)

ⁱ NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^j Korea Food and Drug Administration   (South Korea)

^k WORLD HEALTH ORGANIZATION   (Switzerland)

more..

Author keywords

Clinical trials; Correlates of immunity; Post marketing surveillance; Vaccine quality; Vaccine regulation; Vaccine standardization

Indexed keywords

ENTEROVIRUS 71 VACCINE; IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; ORAL POLIOMYELITIS VACCINE; PNEUMOCOCCUS VACCINE; RESTRICTION ENDONUCLEASE; RNA VACCINE; UNCLASSIFIED DRUG; VACCINE;

ANALYTIC METHOD; CLINICAL TRIAL (TOPIC); DRUG ANTIGENICITY; DRUG EFFICACY; DRUG POTENCY; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; ENTEROVIRUS 71; GLOBAL REGULATORY SCIENCE AGENDA; HAND FOOT AND MOUTH DISEASE; HEALTH CARE ACCESS; HEALTH CARE POLICY; HUMAN; IMMUNE RESPONSE; IMMUNITY; IMMUNIZATION; IMMUNOGENICITY; INFECTION CONTROL; MATHEMATICAL MODEL; NONHUMAN; POLIOMYELITIS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK BENEFIT ANALYSIS; SCIENCE; STANDARDIZATION; STUDY DESIGN; TRANSGENIC MOUSE; VACCINE PRODUCTION; VIRUS VIRULENCE; WORLD HEALTH ORGANIZATION;

BIOMEDICAL RESEARCH; DRUG APPROVAL; GOVERNMENT REGULATION; HUMANS; INTERNATIONAL COOPERATION; PHARMACOVIGILANCE; QUALITY CONTROL; VACCINATION; VACCINES;

EID: 84876739534     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.10.117     Document Type: Review

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