A pipeline meeting is a session where the MEB engages with a company to discuss innovations and plans in the area of drug development for the upcoming period. The primary focus is on the general aspects of the company's product portfolio.
It is important to note that a pipeline meeting is not a comprehensive overview of all upcoming applications. Instead, the discussion should concentrate on the overarching topic, delving into the subject in depth rather than covering everything broadly.
Pipeline meetings provide valuable insights that help to better prepare for future developments. This allows us to effectively anticipate scientific expertise needs, guideline discussions, technological changes, and advancements in drug development.
Pipeline days
The MEB organizes a "Pipeline Day" three times a year, featuring up to three meetings, each lasting 1.5 hours.
Interested companies can apply to participate in a Pipeline Day by following the registration procedure outlined below. The MEB will select participants based on pre-established criteria. The meetings can be conducted in a hybrid format, but it is preferred that the Dutch delegation is physically present at the discussion.
Pipeline Days, registration deadlines, and any additional conditions are determined and communicated annually through our website and the Authorisation Contact Committee (CCR) members. The Central Committee on Research Involving Human Subjects (CCMO) will decide, based on the topic, whether it is relevant to join the particular Pipeline Day.
Registration procedure
It is important that the registration for participation in a Pipeline Day is made by a pharmaceutical company and that the topic proposed for the meeting aligns with the intended theme of the MEB, as described in the call. The company must justify its proposal with a motivation. The registration deadlines are communicated on the MEB website.
If a pharmaceutical company is selected to participate in a specific Pipeline Day, we ask the company to provide a briefing document to help the MEB participants prepare for the meeting.
When preparing the briefing document, please consider the following:
- During the meeting, it is possible to discuss preclinical and clinical aspects, pharmacovigilance, and quality issues. Open-ended questions can also be raised to be discussed with the MEB.
- Specific scientific or regulatory issues should be addressed during the scientific advice phase or through other regulatory procedures.
- Products for which a rapporteur has already been assigned will not be discussed in this meeting.
- Questions already posed in a request for scientific advice will not be discussed during the pipeline meeting.
- Sufficient time should be allocated for discussion after the company's presentation.
After the meeting, the company will be requested to draft an initial version of the minutes.