COMP Oral Explanation 

Expert assistance to answer COMP issues during OD first designation or at the MAA OD maintenance stage.

After submitting an Orphan Drug Designation (ODD) Request, the two appointed coordinators prepare a summary report of the application, which is circulated to all Committee for Orphan Medicinal Products (COMP) members and is discussed at the COMP’s next plenary meeting.

At this stage, the COMP will either adopt a positive opinion or raise a list of questions and invite the sponsor to an Oral Explanation at the next COMP plenary meeting. This is the only opportunity that the sponsor has to convince COMP to adopt a positive opinion on the Application.

Similarly, at MAA stage and for certain follow-on developments the sponsor has to submit a justification for maintenance of the designation based on the data generated during the product’s development. This can also lead to an OE at COMP.

Kinesys Regulatory Advisory Board

The scientists, physicians and epidemiologists, including former COMP members and senior industry executives of Kinesys Regulatory Advisory Board, can help you prepare to address the questions raised by the COMP using their profound experience with other Orphan Drugs to inform their advice to you. In advance of your OE meeting, Kinesys Regulatory Advisory Board experts will challenge your team through mock meetings which will refine the presentation and prepare the main presenters on all aspects of a COMP OE, including the responses to key issues such as prevalence, medical plausibility and significant benefit, and the usual COMP meeting dynamics.