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.
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.
An identified risk or potential risk that could have an impact on the risk-benefit balance…
View definitionThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is…
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