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Single, central platform now mandatory for all periodic safety update reports.
- Source :
- Medical Writing; Sep2016, Vol. 25 Issue 3, p56-57, 2p
- Publication Year :
- 2016
-
Abstract
- The article focuses on the periodic safety update report (PSUR) repository developed by agency for protection of public and animal health through supervision of medicines European Medicines Agency in collaboration with European Union (EU) Member States and industry. It discusses the single storage platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. It mentions its introduction by the EU pharmacovigilance legislation.
- Subjects :
- STORAGE
TECHNICAL reports
SAFETY
PHARMACOLOGY
VIGILANCE committees
Subjects
Details
- Language :
- English
- ISSN :
- 20474806
- Volume :
- 25
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Medical Writing
- Publication Type :
- Academic Journal
- Accession number :
- 119025577