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Related websites
Periodic safety update reports - European Medicines Agency
WEBThis page includes information on periodic safety update reports (psurs), psur submission requirements, psur single assessment procedures (PSUSAs) and the European Union reference dates (EURD) list.
Ema.europa.euThe Preparing and Submitting Summary Reports for Marketed …
WEBMay 23, 2018 · Periodic Safety Update Report (psur) The psur represents a practical and achievable mechanism for summarizing interval safety data, and for conducting an overall safety evaluation. It is a tool for MAHs to conduct systematic analyses of safety data on a regular basis.
Canada.caQuestions and Answers Regarding the Implementation of a Risk
WEBpsur review is recognized as a key component of the Action Plan for health products and links to these three key pillars. A psur is a useful PV tool used to monitor the worldwide safety profile of a particular marketed product and to identify current or …
Canada.caAnnual Summary Report Checklist (including PSUR and PBRER)
WEBChecklist to be completed and accompany an annual summary report which may be provided in psur or PBRER format: Periodic Safety Update Report (psur)/Periodic Benefit Risk Evaluation Report (PBRER) Checklist Descriptions
Canada.caMDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR
WEBDec 16, 2022 · Latest updates. MDCG 2022-21 - Guidance on Periodic Safety Update Report (psur) according to Regulation (EU) 2017/745 - December 2022. News …
Health.ec.europa.euPeriodic Safety Update Reports (PSURs) for medicinal products
WEBDec 18, 2014 · The psur is a periodic assessment of the risk-benefit balance of the product. You need to do this irrespective of the marketing status of the product (whether it is placed on the
Gov.ukE 2 C (R1) Clinical Safety Data Management: Periodic Safety …
WEBThis guideline on the format and content of periodic safety update reports (psurs) is considered particulary suitable for comprehensive reports covering short periods (e.g. six months, one year) often prepared during the initial years following authorisation.
Ema.europa.euGuideline on good pharmacovigilance practices (GVP)
WEBObjectives of the EU reference dates list. The Agency shall make public a list of Union reference dates (hereinafter referred to as list of EU reference dates) and frequency of submission of psurs by means of the European medicines web-portal [DIR Art 107c(7), REG Art 26(1)(g)].
Ema.europa.euWhat Is A Periodic Safety Update Report (PSUR)?
WEBA Periodic Safety Update Report (psur) is a pharmacovigilance document which provides information related to the risk-benefit balance of a drug product post its authorization.
Freyrsolutions.comGuidance on summary reports and issue-related analyses for …
WEBOverview. Summary reports. Issue-related analyses of safety and effectiveness. The Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) came into force on February 22, 2023.
Canada.ca