eCTD NEWS
RECENT NEWS
Loading...
EMA News and press releases: Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
EMA News and press releases: EMA launches pilot project on analysis of raw data from clinical trials Other: Information about the raw data proof-of-concept pilot for industry eSubmissions (eCTD) DADI eAF Portal Guide to Registration now available...
DADI Human Variations eAF User Acceptance Testing (UAT) – Call for Volunteers In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the EMA is pleased to invite applicants to...
EMA: Regulatory and procedural guideline: Procedural guidance for variant strain(s) update to vaccines for protection against human coronavirus (updated) Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry (updated): Regulatory and procedural...
End of content
No more pages to load
Loading...
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 the delivery file (addition of...
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) European Medicines Agency practical guidance...
EMA: Orphans: Regulatory and procedural guidance and forms (updated): https://bit.ly/3mNjzfG Product-information templates - Human (updated): https://bit.ly/3SQI61z Template or form: QRD product-information template version 10.3 (updated): https://bit.ly/3SyQu61 Template or form: QRD product-information annotated template (English) version 10.3 - highlighted (updated): https://bit.ly/3SvM2Vz Template or form:...
End of content
No more pages to load
BLOGS
Loading...
GET IN TOUCH WITH ONIX TODAY!
Contact us using the form below.
If you would prefer to call or email us: +44(0) 1753 257 904 or info@onixls.com
"*" indicates required fields
SUBSCRIBE TO OUR NEWSLETTER
Join our mailing list to receive the latest news and updates from our team: