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Glossary

Briefing Book (or briefing materials)

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Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway.
It should contain company questions, justifications or company positions, and appropriate summary information.

Other glossary definitions

P

Post-market surveillance

All activities carried out by manufacturers in cooperation with other economic operators to institute and…

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P

Paediatric Investigation Plan (PIP)

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary…

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