Pilot Scientific Advice CCMO

Practical information

Requests for advice can be submitted from 8 April 2024 till 31 October 2024.

Scope

In the pilot, advice can be requested on the following topics:

• Regulatory and procedural questions;
• Early phase studies (design, quality pre-clinical data prior to starting a first-in-human trial);
• IMPD-Q questions in the context of a planned clinical trial application;
• Complex clinical trials (methodology and CTIS submission);
• Clinical trials on rare diseases with an unmet medical need;
• Clinical trials with minors;
• Combination studies where both the CTR and MDR/IVDR apply;
• Medical-ethical issues.

The scientific advice does not concern the following areas:

• Questions related to marketing authorization (MAA) of a medicinal product. This falls under the remit of the Medicines Evaluation Board (MEB). Refer to the MEB-website for details on the scientific advice provided by the MEB.

The number of scientific advice during the pilot has been maximised to 10. The requests will be processed in the order of receipt. In the pilot, the advice is free of charge.

Application

The request for advice can be send to ccmo@ccmo.nl. The request must include the following:

• A completed application form. The number of questions is limited to 5. In the application form a precise description of the questions and applicant’s position should be given:
  • The questions should fall within the scope of the pilot and have to be restricted to the conduct of a specific study. The questions need to be specific and open questions should be avoided. It is recommended that questions are phrased in a way to allow for an unambiguous understanding of the question. The scope should be carefully considered in order to avoid too broad or too narrow questions.
  • Each question should be followed by a corresponding, separate applicant’s position including a comprehensive justification of the chosen approach. It should be put forward what the plans are in relation to the specific question complemented by a detailed justification with data and / or literature. All key information about the topic should be sufficiently discussed. Cross-references to the relevant parts of the briefing book (see below) or annexes can be included if additional detail is needed to support the position.
• Briefing book. A stand-alone document specific for the scientific advice, containing:
  • Detailed background information on the product / device / medical-ethical and/or regulatory issue,
  • Description of the development, including relevant data,
  • Presentation of the topics for discussion (the same questions as in the application form, together with the applicants position),
  • If applicable, include previous scientific advice/assessment reports from other NCAs.
• In the application form the applicant can indicate their preference for a written advice with or without a meeting. However, the CCMO will determine the procedure that will be followed depending on the scope and complexity of the questions.

Validation

After receipt of the request for an advice, the request will be validated whether it falls within the scope of the pilot and can be processed. In addition, it will be decided to continue with a full written procedure, or whether an (online) meeting is needed to discuss the request prior to the written advice.

The applicant will be notified as to whether the application has been accepted and which procedure will be followed.

Written procedure

If the request is accepted, the start of the written procedure and timelines will be communicated to the applicant.

Procedure with an online meeting

• If the request is accepted, the online meeting date and the timelines will be communicated to the applicant.
• Two weeks prior to the meeting the presentation prepared for the meeting and list of attendees need to be submitted to ccmo@ccmo.nl.
• The length of the meeting is maximal 60-90 minutes depending on the nature of the questions.
• During the advice meeting, only questions actually contained in the List of Questions will be addressed.
• The applicant is asked to write meeting minutes and to send this to the CCMO within 2 weeks following the meeting. The meeting minutes should only contain what is discussed during the meeting, and no new information should be added. The CCMO will acknowledge receipt of the minutes. The minutes cannot be interpreted as a document issued by the CCMO.

Feedback questionnaire for applicants

As part of the pilot, a questionnaire to provide feedback on the procedure will be sent to the applicant. Participating in the pilot means that applicants commit to complete the feedback questionnaire.

Questions

If you have any remaining questions on the pilot, please send an email to ccmo@ccmo.nl.