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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

U

Unexpected adverse reaction

An adverse reaction, the nature, severity or outcome of which is not consistent with the…

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G

Good Clinical Practice (GCP)

As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording,…

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