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Glossary

Paediatric Investigation Plan (PIP)

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A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children in Europe.

Other glossary definitions

L

Lay Person Summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of…

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I

Investigational Medicinal Product Dossier (IMPD)

Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the…

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