Formulation Working Group

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The Paediatric Committee's (PDCO's) Formulation Working Group (FWG) was established in February 2008. It supports the PDCO in the review process of the quality section of paediatric investigation plans (PIPs).

The FWG reviews the proposed paediatric formulations of a PIP for the first time before the Day 30 PDCO discussion 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 FWG 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 FWG 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.

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