psur | Periodic safety update reports - European Medicines Agency

Keyword	CPC	PCC	Volume	Score	Length of keyword
psur	1.49	0.6	9059	48	4

Keyword	CPC	PCC	Volume	Score
psur	0.66	0.7	8700	93
psoriasis	1.44	0.6	2117	90
psur medical device	1.15	0.7	3768	24
psurlon 5e	0.62	0.8	7564	44
psur template	0.97	0.5	6597	6
psur report	1.36	0.8	4219	80
psur ema	0.59	0.1	6156	55
psur mdr	1.63	0.3	7677	82
psura	0.94	0.3	3140	90
psur mdcg	1.1	0.5	8642	87
psure	0.88	0.1	7900	99
psur full form	0.68	0.8	410	89
psur repository	0.57	0.3	9267	63
psur vs pbrer	1.51	0.4	4655	29
psurlon ringer	1.27	0.5	2104	74
psur1610dnv07	0.08	0.6	6941	88
psur submission	0.11	0.9	8306	40
psur template medical device	0.72	0.2	6781	39
psur pharmacovigilance	1.1	1	5585	33
psur report template	0.13	0.2	176	24
psur submission timelines	0.67	0.6	715	69

Search Results related to psur on Search Engine

Periodic safety update reports - European Medicines Agency
europa.eu

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

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.

DA: 41 PA: 59 MOZ Rank: 1

Understanding PSURs: A Guide to Periodic Safety Update Reports
regdesk.co

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: 36 PA: 25 MOZ Rank: 9

Providing Postmarketing Periodic Safety Reports in the ICH …
fda.gov

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,

DA: 70 PA: 100 MOZ Rank: 33

PSUR | Pharmacovigilance
allaboutpharmacovigilance.org

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: 20 PA: 22 MOZ Rank: 84

PSUR Explained: Everything You Need to Know About Periodic …
drug-card.io

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: 29 PA: 5 MOZ Rank: 97

Periodic safety update reports (PSUR) - CBG/MEB
cbg-meb.nl

https://english.cbg-meb.nl/topics/mah-periodic-safety-update-reports-psur

WEBA Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorisation.

DA: 92 PA: 58 MOZ Rank: 36

Guideline on good pharmacovigilance practices (GVP)
europa.eu

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-

DA: 63 PA: 65 MOZ Rank: 100

MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR
europa.eu

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.

DA: 16 PA: 26 MOZ Rank: 11

Periodic Safety Update Reports - Therapeutic Goods …
tga.gov.au

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).

DA: 13 PA: 65 MOZ Rank: 78

Periodic Safety Update Report compliant with MDR - Johner Institute
johner-institute.com

https://www.johner-institute.com/articles/regulatory-affairs/and-more/periodic-safety-update-report-psur/

WEBThe MDR and IVDR require either a “ Post-market surveillance report ” or a “ Periodic safety update report ” from medical product manufacturers. The periodic safety update report is abbreviated as “PSUR”, the post-market surveillance reports as “PMS report”.

DA: 40 PA: 48 MOZ Rank: 29