18117 results
-
List item
Annual re-assessment: questions and answers
Last updated: 08/02/2019Annual re-assessment: questions and answers … 1. What is the annual re-assessment? In exceptional circumstances … be linked to the annual re-assessment of the conditions mentioned …
-
List item
CAT: Agendas, minutes and reports (updated)
Last updated: 08/02/2023CAT: Agendas, minutes and reports … agendas, minutes and meeting reports of the plenary meetings of … committee that is responsible for assessing the quality, safety and efficacy …
-
List item
Quality assessors training
London, from 27/10/2009 to 28/10/2009, Last updated: 27/10/2009Quality assessors training … Documents Agenda - Quality Assessors Training PDF icon application/pdf … 26/10/2009 Generic Writing an assessment report - Malcolm Dash PDF icon application/pdf … -
List item
PSUR roadmap: joint industry/assessor training
European Medicines Agency, London, UK, 22/09/2017, Last updated: 18/10/2017PSUR roadmap: joint industry/assessor training … national competent authority assessors' training aims to achieve … the role of periodic safety assessment reports (PSUR) in the product lifecycle … -
List item
Periodic safety update reports (PSURs)
Last updated: 27/07/2022Periodic safety update reports (PSURs … includes information on A report prepared by the marketing-authorisation … under 'Periodic safety update reports - questions and answers' …
-
List item
Variations requiring assessment (veterinary medicines)
Last updated: 20/01/2022Variations requiring assessment (veterinary medicines … application. Rapporteur circulates assessment report to Committee for Veterinary … of variations requiring assessment according to Article 62 of …
-
List item
News: Guidance on submission of single assessment PSURs published
Last updated: 24/06/2013ance on submission of single assessment PSURs published … submit periodic safety update reports (PSURs) for medicines subject … to European Union single assessment via its eSubmission Gateway … -
List item
EudraVigilance: electronic reporting
Last updated: 15/02/2022EudraVigilance: electronic reporting … organisations that electronically report ICSRs to A centralised European … relating to the detection, assessment, understanding and prevention …
-
List item
PDCO: Agendas, minutes and reports (updated)
Last updated: 08/02/2023PDCO: Agendas, minutes and reports … the agendas, minutes and reports of the plenary meetings of … committee that is responsible for assessing the content of paediatric …
-
List item
Environmental risk assessment of veterinary medicines
Last updated: 02/06/2020Environmental risk assessment of veterinary medicines … is summarised in the assessment report of the Committee for Veterinary … medicine's European Public Assessment Report (EPAR). The ERA is tier-based …
-
List item
Reporting a quality defect to EMA
Last updated: 03/05/2018Reporting a quality defect to EMA … on product quality defects assessment and reporting obligations, see Quality …
-
List item
Workshop on paediatric formulations for assessors in national regulatory agencies
London, UK, 31/05/2010, Last updated: 05/10/2010paediatric formulations for assessors in national regulatory agenci … 05/2010 London, UK Documents Report: Workshop on paediatric formulations … paediatric formulations for assessors in national regulatory agencies … -
List item
Renewal and annual re-assessment of marketing authorisation
Last updated: 20/06/2022Renewal and annual re-assessment of marketing authorisation … under 'Renewal and annual re-assessment of marketing authorisation' … Renewal , on the basis of the A report prepared by the marketing-authorisation …
-
List item
Paediatric development and juvenile animal studies assessors meeting
London, 03/07/2009, Last updated: 02/12/2009and juvenile animal studies assessors meeting … non-clinical and clinical assessors involved in paediatric-investigation-plan … animal testing. Documents Report on paediatric development … -
List item
Periodic safety update report information day
European Medicines Agency, London, UK, 28/10/2016, Last updated: 14/06/2016Periodic safety update report information day … of periodic safety update report (PSUR) single assessment procedures, with a particular … understanding of the single assessment. The roadmap is key to optimising … -
List item
News: EMA publishes 2013 annual report
Last updated: 30/04/2014EMA publishes 2013 annual report … published today its 2013 annual report. In 2013, the EMA's Committee … Union (EU) level. The annual report also highlights some of the … -
List item
Reporting safety information on clinical trials
Last updated: 29/03/2022Reporting safety information on clinical … sponsors must report the information below for assessment by the relevant EU and EEA … INFORMATION DESCRIPTION WHERE TO REPORT Suspected unexpected An adverse …
-
List item
Workshop on paediatric formulations for assessors in national regulatory agencies
European Medicines Agency, London, UK, 08/11/2011, Last updated: 31/01/2012paediatric formulations for assessors in national regulatory agenci … Registration closed. Documents Report - Workshop on paediatric … paediatric formulations for assessors in national regulatory agencies … -
List item
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August … Pharmacovigilance Risk Assessment Committee - the committee … committee that is responsible for assessing all aspects of the risk management … -
List item
Reporting requirements for marketing-authorisation holders
Last updated: 22/01/2016Reporting requirements for marketing-authorisation … relating to the detection, assessment, understanding and prevention … eXtended EudraVigilance Product Report Message (XEVPRM) format …
-
List item
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021
PRAC, Last updated: 07/05/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021 … evidence, including cases reported to the European database … between the vaccine and the reported cases of facial swelling … -
List item
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
PRAC, Last updated: 15/01/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January … First monthly summary safety report for COVID-19 vaccine Comirnaty … will evaluate summary safety reports submitted monthly by marketing … -
List item
News: EMA publishes annual report 2021
Last updated: 10/06/2022EMA publishes annual report 2021 … News 10/06/2022 EMA annual report 2021 EMA’s annual report 2021 published today provides … related to the scientific assessment and supervision of medicines … -
List item
Variations not requiring assessment (veterinary medicines) (updated)
Last updated: 01/02/2023Variations not requiring assessment (veterinary medicines … classification of variations requiring assessment according to Article 62 of … working party leading the assessment of an application. co-rapporteur …
-
List item
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
PRAC, Last updated: 06/08/2021the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August … the Pharmacovigilance Risk Assessment Committee - the committee … committee that is responsible for assessing all aspects of the risk management …