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Periodic safety update reports - European Medicines Agency
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs
WEBPSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety ...
DA: 72 PA: 60 MOZ Rank: 37
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Creating a Periodic Safety Update Report (PSUR) that Complies …
https://www.greenlight.guru/blog/creating-periodic-safety-update-report-psur
WEBFebruary 1, 2023. The Periodic Safety Update Report (PSUR) is one of the new postmarket surveillance (PMS) activities required by EU MDR and EU IVDR. These new regulations represent a complete overhaul of the past EU regulations for medical devices and in-vitro diagnostic devices—notably in the addition of more rigorous PMS and …
DA: 67 PA: 87 MOZ Rank: 85
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Understanding PSURs: A Guide to Periodic Safety Update Reports
https://www.regdesk.co/understanding-psurs-a-guide-to-periodic-safety-update-reports/
WEBApr 13, 2023 · What is a PSUR? A PSUR is a comprehensive report that provides an evaluation of the safety and performance of a medical device or in vitro diagnostic product over a defined period of time. The report summarizes the manufacturer’s post-market surveillance activities, including adverse event reporting, complaint handling, and …
DA: 75 PA: 33 MOZ Rank: 28
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PSUR | Pharmacovigilance
https://allaboutpharmacovigilance.org/29-periodic-safety-update-reports-psurs-periodic-benefit-risk-evaluation-reports-pbrer/
WEBDec 11, 2019 · Periodic safety update report (PSUR) provides a periodic and comprehensive assessment of the worldwide safety data of a marketed drug. Over time it was recognized that the risk of the marketed drug should be assessed in the light of its benefits and change in the risk estimate overtime.
DA: 71 PA: 1 MOZ Rank: 61
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Providing Postmarketing Periodic Safety Reports in the ICH …
https://www.fda.gov/media/85520/download
WEBguideline replaces the PSUR with the PBRER for postmarketing periodic safety reporting, and describes the recommended format, content, and timing of PBRER submissions. Like the PSUR,
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MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR
https://health.ec.europa.eu/latest-updates/mdcg-2022-21-guidance-periodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en
WEBDec 16, 2022 · MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022 - European Commission.
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Periodic Safety Update Reports (PSURs) for medicinal products
https://www.gov.uk/guidance/periodic-benefit-risk-evaluation-reports-for-medicinal-products
WEBDec 18, 2014 · Overview. You must submit a periodic safety update report (PSUR) for all approved medicinal products in the UK (unless they are covered by the derogation given in the Human Medicines Regulations ...
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PSUR Explained: Everything You Need to Know About Periodic …
https://drug-card.io/blog/psur-explained-everything-you-need-to-know-about-periodic-safety-update-reports/
WEBApr 9, 2023 · A PSUR is a report that provides a detailed evaluation of the safety and efficacy of a medicinal product. It is a requirement for all medicinal products authorized in the European Union (EU), and it must be submitted to the EMA at predefined intervals.
DA: 75 PA: 26 MOZ Rank: 20
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Guideline on good pharmacovigilance practices (GVP)
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-report_en.pdf
WEBPSUR EU regional appendix, sub-section “Summary of ongoing safety concerns” 58 VII.C.5.4. PSUR EU regional appendix, sub-section “Reporting of results from post-
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Periodic Safety Update Reports - Therapeutic Goods …
https://www.tga.gov.au/resources/resource/guidance/risk-management-plans-medicines-and-biologicals/periodic-safety-update-reports
WEBLast updated. 29 March 2019. A Periodic Safety Update Report (PSUR) is a systematic review of the global safety data of an approved medicine that becomes available to you during a defined time period. PSURs are also referred to as Periodic Benefit–Risk Evaluation Reports (PBRERs).
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