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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

E

European Directorate for the Quality of Medicines (EDQM)

The quality of medicines and healthcare products in Europe is harmonized through different initiatives under…

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A

Anonymization Report (AR)

Part of the Policy 70 submission package. It should describe the methodology of the anonymisation…

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