eCTD Industry Update (12th June 2023)
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 – Session 1 , Online, 15:00 – 15:30 Amsterdam time (CET), from 15/06/2023 to 15/06/2023 […]
eCTD Industry Update (5th June 2023)
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 Service (PMS) Q&A clinics – Session 1 , Online, 15:00 – 15:30 Amsterdam time (CET), from 15/06/2023 to 15/06/2023 Human […]
eCTD Industry Update (1st June 2023)
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, 15:30 – 17:00 Amsterdam time (CEST), from 10/05/2023 to 10/05/2023 (updated) CMDh UPDATE – ‘Blue box’ require/ Tracked Version
eCTD Industry Update (25th May 2023)
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 An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version […]
eCTD Industry Update (15th May 2023)
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 us for the webinar on Wednesday June 7, 2023 at 11am ET / 4pm GMT. […]
eCTD Industry Update (9th May 2023)
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 these updates info@onixls.com CMDh Assessment report template for the nitrosamine risk assessment for the outcome […]
eCTD Industry Update (2nd May 2023)
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 Version (updated) Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised […]
eCTD Industry Update (25th April 2023)
EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Template or form: Template for sections A to E for the scientific part of the application for orphan designation (updated) eSubmissions (eCTD) Updated PLM Portal eAF timeline now available Please find an updated version of the PLM Portal eAF Human Variations Forms timeline. […]
eCTD Industry Update (18th April 2023)
EMA Regulatory and procedural guideline: Guide for rapporteurs and coordinators on the multinational assessment teams (updated) Template or form: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical Clinical Trials Information System (CTIS): Walk-in clinic – March 2023 , Online, 16:00 – 17:00 Amsterdam time (CET), from 16/03/2023 to 16/03/2023 (updated) Clinical Trials Information […]
eCTD Industry Update (11th April 2023)
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 (PRIME) Medical devices (updated)
