eCTD NEWS
RECENT NEWS
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EMA Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (updated) Human variations electronic Application Form (eAF) & Product Management...
EMA Clinical Trials Information System Webinar: Second Year of Transition , Online, 13:00 - 17.30 Amsterdam time (CET), from 04/07/2023 to 04/07/2023 (updated) Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission , Online,...
EMA Regulatory and procedural guideline: Good practices for industry for the prevention of human medicinal product shortages Template or form: QRD Appendix V - Adverse-drug-reaction reporting details(updated) eSubmissions (eCTD) Updated PLM Portal eAF Release notes now available...
JOINT WEBINAR: FRAMEWORK SOLUTIONS (ONIX)/IQVIA The implementation of eCTD 4.0 offers several benefits to organisations, improved efficiency and accuracy in regulatory submissions, enhanced collaboration with regulatory authorities, and the ability to use new technologies and...
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EMA Regulatory and procedural guideline:Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products (updated) eSubmissions (eCTD) PSUR Repository (NCA UI) Go-live 3rd July 2023 We are pleased to inform you that...
EMA Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 EudraVigilance and Signal Management information day , European Medicines Agency, Amsterdam, the Netherlands, 09:30-17:00 CET, from 21/11/2023 to 21/11/2023 European Medicines Agency practical...
EMA Paediatric investigation plans: Templates, forms and submission dates (updated) Regulatory and procedural guideline: Guidance on paediatric submissions (updated) Clinical Trials Information System: training and support (updated) Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics...
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