Voisin Consulting Life Sciences glossary icon
Glossary

Company Core Data Sheet (CCDS)

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A document prepared by the marketing authorization holder containing, in addition to safety information, material related to indications, dosing, pharmacology, and other information concerning the product.  

Other glossary definitions

I

Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from regulatory authorities. Investigational…

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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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