eCTD NEWS
RECENT NEWS
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EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Human variations electronic application forms public training , Online, 10:00 - 11:30 Amsterdam time (CET), from 15/12/2022 to 15/12/2022 (updated)
EMA Human variations electronic application forms Q&A clinics – session 5 , Online, 14:30 - 15:00 Amsterdam time (CET), from 19/12/2022 to 19/12/2022 Regulatory and procedural guideline: EudraVigilance registration documents (updated) Human Variations electronic application...
eSubmission: - eSubmission Gateway XML delivery file update for Raw Data submissions: An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to...
EMA Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (updated) Instructor's guide: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10 (updated)...
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EMA PRIME: priority medicines (updated) MHRA Register medical devices to place on the market - 27 March 2023 – Guidance
EMA: Newsletter: CTIS newsflash – 17 March 2023 eSubmissions (eCTD): 17-03-2023 Common Repository Go-Live on 20th of March 2023 (relevant for NCAs only) We are pleased to inform you that the next version of the Common Repository introducing the ‘Basic...
EMA Newsletter: CTIS newsflash - 10 March 2023 Other: European Medicines Agency’s data protection notice for the European Union (EU) Metadata Catalogue Other: Orphan medicines figures 2000-2022 (updated) Report: Annual report on the use of the special contribution for orphan medicinal products - 2022 Report: Key...
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