Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 – 10 February 2022
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-february-2022
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
https://www.ema.europa.eu/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
https://www.ema.europa.eu/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) 24-27 January 2022
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-january-2022
Clinical trials for medicines: apply for authorisation in the UK
https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#full-publication-update-history
Changes to the guidance document Temporary authorisation of human medicinal products HMV4
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-befristete-zulassung-ham.html
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 13 January 2022
Meeting highlights from the PRAC 10 – 13 January 2022
Pharmacovigilance Inspection Metrics April 2020 to March 2021 – MHRA
Pharmacovigilance Inspection Metrics April 2020 to March 2021 – MHRA
PRAC recommendations on signals
https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-29-november-2-december-2021-prac-meeting_en.pdf
Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD
https://www.ema.europa.eu/en/documents/other/guidance-electronic-submission-information-investigational-medicinal-products-human-use-extended_en.pdf