Paediatric Formulation Operational Expert Group

The Paediatric Formulation Operational Expert Group (PFOEG) supports the Paediatric Committee (PDCO) in the review process of the quality section of paediatric investigation plans (PIPs).

The PFOEG, at the request of the PDCO, reviews the proposed paediatric formulations described in a PIP and can suggest modifications to the PDCO.

The group's comments are reflected in the summary report and, if endorsed by the PDCO, in the request for modification sent to the applicant.

The PFOEG may also be involved later on in the process, once the responses to the request for modification have been received from the applicants.

Composition

The PFOEG is currently composed of 13 formulation experts from the PDCO, the Quality Working Party and additional members from medicines regulatory authorities in European Union Member States, hospitals and academia. All members have signed a public declaration of interests and confidentiality undertaking form.

Two representatives from the United States Food and Drug Administration also attend the meetings by teleconference as observers. These representatives are covered by the Agency's confidentiality arrangement with the FDA.