Link: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs
Description: WebPSURs are documents that evaluate the risk-benefit balance of medicines after authorisation. Learn about PSUR requirements, submission, assessment and guidance …
DA: 67 PA: 82 MOZ Rank: 92
Link: https://allaboutpharmacovigilance.org/29-periodic-safety-update-reports-psurs-periodic-benefit-risk-evaluation-reports-pbrer/
Description: WebPSUR or PBRER is a report that assesses the safety, efficacy, and effectiveness of a marketed drug over its lifecycle. Learn how to prepare, format, and submit PSUR/PBRER …
DA: 73 PA: 45 MOZ Rank: 36
Link: https://www.regdesk.co/understanding-psurs-a-guide-to-periodic-safety-update-reports/
Description: WebPSURs are reports that evaluate the safety and performance of medical devices or in vitro diagnostic products over a defined period of time. Learn what PSURs are, what …
DA: 96 PA: 92 MOZ Rank: 41
Link: https://www.fda.gov/media/85520/download
Description: WebLearn how to use the ICH E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) instead of the PADER, PAER, or PSUR to satisfy the periodic postmarketing safety …
DA: 70 PA: 79 MOZ Rank: 6
Link: https://www.gov.uk/guidance/periodic-benefit-risk-evaluation-reports-for-medicinal-products
Description: WebLearn how to submit periodic safety update reports (PSURs) or periodic benefit risk evaluation reports (PBRERs) for approved medicinal products in the UK. Find out when, …
DA: 5 PA: 14 MOZ Rank: 83
Link: https://www.greenlight.guru/blog/creating-periodic-safety-update-report-psur
Description: WebPSUR is a postmarket surveillance report required by EU MDR and IVDR for moderate and high risk medical devices and IVDs. Learn the difference between PSUR and PMSR, …
DA: 48 PA: 71 MOZ Rank: 73
Link: https://drug-card.io/blog/psur-explained-everything-you-need-to-know-about-periodic-safety-update-reports/
Description: WebPSURs are reports that evaluate the safety and efficacy of medicinal products authorized in the EU. They are prepared by the MAHs and submitted to the EMA at predefined …
DA: 33 PA: 15 MOZ Rank: 93
Link: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-report-superseded_en.pdf
Description: WebThis document provides guidance on the periodic safety update report (PSUR), a key element of pharmacovigilance. It covers the objectives, principles, format, contents, …
DA: 69 PA: 42 MOZ Rank: 42
