eCTD NEWS
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EMA EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other major disruptions News and press releases: New features further strengthen Priority Medicines scheme...
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...
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...
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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 data standards. Register to join...
EMA IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated) Provisional mandate, objectives and rules of procedure for the Nitrosamines Safety Operational Experts Group (NS OEG) Medical devices (updated) Contact us to discuss...
EMA Template or form: CHMP protocol assistance scientific advice briefing document template (updated) Newsletter: News bulletin for small and medium-sized enterprises - Issue 58 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes / Clean...
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