Meeting highlights from the PRAC 8-11 April 2024 19 April 2024 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024
Clinical Trials Information System Webinar: Last Year of Transition 16 April 2024 All news https://www.ema.europa.eu/en/events/clinical-trials-information-system-webinar-last-year-transition
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024 12 April 2024 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024
Providing Regulatory Submissions in Electronic Format: IND Safety Reports – Guidance for industry 8 April 2024 All news USA-Providing-Regulatory-Submissions-in-Electronic-Format_-IND-Safety-Reports_01Apr2024-1Download
Regulatory information – adjusted fees for applications to EMA from 1 April 2024 5 April 2024 All news https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2024
Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials – Scientific guideline 29 March 2024 All news https://www.ema.europa.eu/en/guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal-products-clinical-trials-scientific-guideline
ANSM – User guide February 2024 25 March 2024 All news 20240306-le-livret-de-lusager-maj-fev-2024-1Download
Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU 21 March 2024 All news https://www.ema.europa.eu/en/news/accelerating-stakeholder-collaboration-enhance-clinical-trials-environment-eu
When you’re pregnant, it’s (always) important to take the right kind of medicine! 19 March 2024 All news https://ansm.sante.fr/actualites/enceinte-les-medicaments-cest-toujours-pas-nimporte-comment
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024 15 March 2024 All news https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-mars-2024-4-7-mars
