Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations

Therapeutic Innovation and Regulatory Science

Volumn 49, Issue 6, 2015, Pages 840-851

  Naik, Paulami ^a   Umrath, Thomas ^b   van Stekelenborg, John ^c   Ruben, Regina ^d   Abdul Karim, Nasiba ^e   Boland, Robert ^c   Ibara, Michael ^f   Ekuta, Jethro ^c   Washburn, Dana ^g   Stergiopoulos, Stella ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

^c JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^d ParagonRx International LLC   (United States)

^e SUNOVION PHARMACEUTICALS INC   (United States)

^f PFIZER INC   (United States)

^g PAREXEL INTERNATIONAL   (United States)

Author keywords

adverse events on social media; drug safety; pharmacovigilance; regulatory harmonization; social media monitoring

Indexed keywords

ARTICLE; DRUG INDUSTRY; DRUG SURVEILLANCE PROGRAM; HEALTH; HUMAN; MONITORING; PRIORITY JOURNAL; SOCIAL MEDIA; STANDARD;

EID: 84944703957     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479015587362     Document Type: Article

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