CCMO starts pilot scientific advice on 8 April 2024
On 8 April 2024, the CCMO will start a pilot evaluating the feasibility of providing scientific advice as a new task of the CCMO. The pilot runs till 31 October 2024.
Important update 15-07-2024: the stated deadline has been adjusted. The pilot will run at least until 31 January 2025.
Since the implementation of the CTR, MDR and IVDR, the CCMO is regularly approached by sponsors with a request for advice prior to the submission of the clinical trial application. The pilot will focus primarily on the feasibility of a scientific advice procedure by the CCMO. In addition, the pilot will look at the positioning of this advice in relation to the other forms of scientific advice (national and European). The number of scientific advice during the pilot has been maximised to 10, and they will be processed in the order of receipt. In the pilot, the advice is free of charge.
Applications, with a completed application form and a briefing book, can be submitted from April 8th to ccmo@ccmo.nl.
More information about the criteria and the application form can be found on the webpage Pilot Scientific Advice CCMO.