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 in:Drug safety 2021-08, Vol.44 (8), p.843-852
Main Authors: Kugener, Veronique F., Freedland, Eric S., Maynard, Kenneth I., Aimer, Omar, Webster, Peggy S., Salas, Maribel, Gossell-Williams, Maxine
Format: Article
Language:English
Subjects:
Antigens
Best practice
Biomarkers
Cancer therapies
Cardiovascular disease
Collaboration
Consortia
Cytokines
Diabetes
Drug Safety and Pharmacovigilance
FDA approval
Gene therapy
Genomes
Knowledge sharing
Leading
Leading Article
Marketing
Medicine
Medicine & Public Health
Patient safety
Pharmaceutical industry
Pharmacology
Pharmacology/Toxicology
Pharmacovigilance
Product safety
Regulatory approval
Risk assessment
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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