Non-clinical Working Group
The Paediatric Committee's (PDCO's) Non-clinical Working Group (NcWG) was established by the PDCO in November 2008. It supports the PDCO in the review process of the non-clinical section of paediatric investigation plans (PIPs).
The NcWG reviews the non-clinical part of a PIP for the first time just before the middle of the procedure, at day 60 of the PDCO discussion, before the clock stop. It can suggest modifications to the PDCO.
The group's comments are reflected in the request for modification sent to the applicant.
The NcWG may also be involved later on in the process, once the responses to the request for modification have been received from the applicants.
The NcWG is currently composed of 12 non-clinical experts from the PDCO, the Safety Working Party of the Committee for Medicinal Products for Human Use (CHMP) and and additional members from medicines regulatory authorities in European Union Member States. 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.