Clinical Trials Regulation (EU) N° 536/2014 version 6.1 – Q&A 13 June 2022 All news EU-QA-regulation536-2014_v6.1_May2022-2Télécharger
New version of the French Good Pharmacovigilance Practices 7 June 2022 All news France-BONNES-PRATIQUES-DE-PHARMACOVIGILANCE-MAY-2022-1Télécharger
EU_EMA_PSUR eSubmission 3 June 2022 All news european-medicines-agency-PNG-7Télécharger EU_EMA_PSUR-eSubmission_-Projects_24May2022-2Télécharger
Authorisation for early access to medicines: HAS evaluation doctrine 30 May 2022 All news France_acces_precoces_-_doctrine_27Apr2022-1Télécharger
China : release of MedDRA Coding Guidance for Adverse DrugReaction (ADR) Reports 23 May 2022 All news https://baipharm.chemlinked.com/news/china-releases-meddra-coding-guidance-for-adverse-drug-reaction-adr-reports
Medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency 20 May 2022 All news https://www.ema.europa.eu/en/documents/other/monitoring-medical-literature-entry-relevant-information-eudravigilance-database-european-medicines_en.pdf
Questions and Answers Regarding the Implementation of a Risk-Prioritized Periodic Safety Update Report Regulatory Review Pilot (PSUR-RRP) at Health Canada 16 May 2022 All news Canada_QandA_Regarding-the-Implementation-of-a-Risk-Prioritized-PSUR-Regulatory-Review-Pilot-PSUR-RRP-at-Health-Canada-3Télécharger
Australia : Good Clinical Practice (GCP)- inspection program 12 May 2022 All news Australia-Good-Clinical-Practice-GCP-inspection-program_Apr2022-1Télécharger
Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland 9 May 2022 All news Ireland-guide-to-CTs-conducted-under-the-ctr-in-ireland_v3_29APR2022-2Télécharger
PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP 6 May 2022 All news EU-ANNEX-IV-TO-PROCEDURE-FOR-CONDUCTING-GCP-INSPECTIONS-REQUESTED-BY-THE-CHMP_-SPONSOR-AND-CRO_02May2022-2Télécharger
