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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

M

Markov Model

Stochastic multi-state transition models. Transition between different states in the model are based upon pre-defined…

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D

Data lock point (DLP)

For a periodic safety update report (PSUR), the date designated as the cut-off date for…

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