Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities

This review is intended to present perspectives from the US experience in enhancing pharmacovigilance on current practices and future opportunities. Best practices concepts could be applied worldwide through the presentation of how three pillars of pharmacovigilance: (1) medical and scientific excel...

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Bibliographic Details
Published inDrug safety Vol. 44; no. 8; pp. 843 - 852
Main Authors Kugener, Veronique F., Freedland, Eric S., Maynard, Kenneth I., Aimer, Omar, Webster, Peggy S., Salas, Maribel, Gossell-Williams, Maxine
Format Journal Article
LanguageEnglish
Published Cham Springer International Publishing 01.08.2021
Springer Nature B.V
Subjects
Antigens
Best practice
Biomarkers
Cancer therapies
Cardiovascular disease
Collaboration
Consortia
Cytokines
Diabetes
Drug Safety and Pharmacovigilance
FDA approval
Gene therapy
Genomes
Humans
Knowledge sharing
Leading
Leading Article
Marketing
Medicine
Medicine & Public Health
Patient safety
Pharmaceutical industry
Pharmacology
Pharmacology/Toxicology
Pharmacovigilance
Product safety
Regulatory approval
Risk assessment
United States > US
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Summary:This review is intended to present perspectives from the US experience in enhancing pharmacovigilance on current practices and future opportunities. Best practices concepts could be applied worldwide through the presentation of how three pillars of pharmacovigilance: (1) medical and scientific excellence, (2) operational and compliance excellence, and (3) knowledge sharing and experts development in the field could serve as a framework for the establishment of an efficient and successful global pharmacovigilance system.
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-021-01078-8