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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.

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Regulatory Strategy & Submissions

Design and implementation of global patient-centric regulatory strategies to ensure expedited product…
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Cell, Gene and Tissue Therapies

Gene therapy, somatic or stem cell therapy and tissue engineering are at…

Other glossary definitions

C

Competent Authority

Is responsible for the authorization of medicines / medical devices and for ensuring that medicines…

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R

Real World Study (RWS)

Studies investigating health interventions whose design does not follow the design of a highly-controlled RCT…

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