Health Canada Psur Guidance

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Preparing and Submitting Summary Reports for Marketed …

(6 days ago) Products regulated under the Food and Drug Regulations In accordance with section C.01.018 of the Food and Drug RegulationsFootnote 2, the MAH must, … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/preparing-submitting-summary-reports-marketed-drugs-natural-health-products-guidance-industry.html

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Understanding PSURs: A Guide to Periodic Safety …

(5 days ago) WebApr 13, 2023. Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market …

https://www.regdesk.co/understanding-psurs-a-guide-to-periodic-safety-update-reports/

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Periodic safety update reports - European Medicines …

(7 days ago) WebA PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health (e.g. an update of the information …

https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs

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He a lth C a n a da Re g u la to r y Rev ie w Pilo t (PS UR

(5 days ago) WebImplementation of a risk-prioritized PSUR-RRP will allow Health Canada to focus and target more efficiently the review and management of PSURs. In addition, it will further …

https://www.pharmya.com/wp-content/uploads/2022/05/Canada_QandA_Regarding-the-Implementation-of-a-Risk-Prioritized-PSUR-Regulatory-Review-Pilot-PSUR-RRP-at-Health-Canada-3.pdf

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PSUR Explained: Everything You Need to Know About …

(6 days ago) WebThe PSUR is a vital tool for monitoring the safety of medicinal products, as it provides a comprehensive assessment of the safety profile of a drug. This article will explain everything you need to know about …

https://drug-card.io/blog/psur-explained-everything-you-need-to-know-about-periodic-safety-update-reports/

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Canada regulations news for medical devices and IVDs

(4 days ago) WebThe amendments to the Medical Devices Regulations that published in the Canada Gazette, Part II (CGII) in 2020 are: The preparation, retention and submission of …

https://www.medtechdive.com/spons/canada-regulations-news-for-medical-devices-and-ivds/611209/

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HEALTH CANADA’S PHARMACOVIGILANCE ACTIVITIES FOR …

(3 days ago) WebWHO Definition of a Safety Signal. “Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely …

https://capra.ca/_uploads/58c6d459d94f4.pdf

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Drug Details - covid-vaccine.canada.ca

(6 days ago) WebHealth Canada will continue to monitor any new emerging evidence from all available sources as part of its post-authorization monitoring for Veklury. PSUR # 242336: 2022 …

https://covid-vaccine.canada.ca/info/paat-SBD00491-veklury-en.html

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MHRA and Health Canada release new clinical safety reporting …

(7 days ago) WebThe UK’s Medicines and Healthcare products Regulatory Agency ( MHRA) and Health Canada have jointly published new guidance to improve clinical trial safety via …

https://www.europeanpharmaceuticalreview.com/news/158094/mhra-and-health-canade-release-new-clinical-safety-reporting-guidance/

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CANADA: Summary Reports required - Thema Med

(2 days ago) WebThe guidance document Guidance on summary reports and issue-related analyses for Medical Devices has been purposely published to better understand and …

https://www.thema-med.com/en/2022/12/15/canada-summary-reports-required/

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Health Canada Guidance on Summary Reports RegDesk

(5 days ago) WebScope and Objectives. Health Canada also outlines the parties to which the regulatory requirements described herein apply. According to the guidance, the …

https://www.regdesk.co/health-canada-guidance-on-summary-reports/

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PSUR Pharmacovigilance

(5 days ago) WebPeriodic safety update report (PSUR) provides a periodic and comprehensive assessment of the worldwide safety data of a marketed drug. Over time it …

https://allaboutpharmacovigilance.org/29-periodic-safety-update-reports-psurs-periodic-benefit-risk-evaluation-reports-pbrer/

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Health Canada: new PMS requirements for Medical Devices

(1 days ago) WebFloor 4. Philadelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. On 23 December 2020, new Post-Market Surveillance (PMS) requirements for …

https://www.thema-med.com/en/2021/01/25/health-canada-new-pms-requirements-medical-devices/

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Health Canada Guidance on Issue-Related Analyses for Medical

(3 days ago) WebThe present Health Canada guidance details the regulatory requirements that summary reports should meet. According to the document, such a report shall …

https://www.regdesk.co/health-canada-on-issue-related-analysis-for-medical-devices/

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Health Canada Summary Reports/Issue-Related Analyses

(7 days ago) WebThis message was posted by a user wishing to remain anonymous. Hi, My company sells Class I and II medical devices into Canada. I am looking for some …

https://connect.raps.org/discussion/health-canada-summary-reportsissue-related-analyses

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