eCTD Industry Update (7th August 2023)
EMA 04/08/2023 Newsletter: CTIS newsflash – 4 August 2023 eSubmissions (eCTD) 01-08-2023 Updated PLM Portal eAF Guide to Registration is now available Please find an updated version of the PLM Portal eAF Guide to Registration here. MHRA Register medical devices to place on the market CE marking recognition for medical devices and in vitro diagnostics […]
eCTD Industry Update (24th July 2023)
FDA 17/07/2023 Medical Device – Qualification of Medical Device Development Tools 19/07/2023 0356h Forms
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 (31st January 2023)
EMA Clinical Trials Information System (CTIS): online modular training programme(updated) FDA Update on In-Person Face-to-Face Formal Meetings with FDA
