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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

CE Marking

CE certification verifies to regulators in Europe that medical devices meet all quality, safety and…

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Q

Quality-by-Design(QbD)

Quality by design (QbD) is an approach that aims to ensure the quality of medicines…

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