Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
Updated on 30 November 2021
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-29-november-2-december-2021
FDA Adverse Event Reporting System (FAERS) Electronic Submissions
Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS
List of medicines under additional monitoring
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0.pdf
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-8-11-november-2021
XEVMPD Data-Entry Tool (EVWEB) user manual
https://www.ema.europa.eu/en/documents/other/extended-eudravigilance-medicinal-product-dictionary-xevmpd-data-entry-tool-user-manual_en.pdf
List of medicines under additional monitoring
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-october-2021