eCTD NEWS
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EMA IRIS guide for applicants - How to create and submit scientific applications for industry and individual applicants (updated) CMDh Update: Step 2 - No nitrosamine detected response template Update: EMA/CMDh explanatory notes on Variation Application Form -...
FDA Specifications for File Format Types Using eCTD Specifications
EMA Newsletter: News bulletin for small and medium-sized enterprises - Issue 56 eSubmissions (eCTD) Questions and Answers document from the public webinar “DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live” held on 12th...
eSubmissions (eCTD) The 1st DADI newsletter has been published on the EMA website The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU...
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EMA European Medicines Agency post-authorisation procedural advice for users of the Centralised Procedure Clean Version / Tracked Version (updated) European Medicines Agency Pre-authorisation guidance - Clean Version / Tracked Version (updated) Regulatory and procedural guideline: Validation checklist for Type II...
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 forms public training , Online,...
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