investigational medicinal product dossier
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- Definition
- Request for a clinical trial authorisation (CTA) in the EU. An IMPD should include summaries of information related to the quality, manufacture and control of the investigational medicinal product, data from non-clinical studies and from its clinical use.
- Abbreviation for
- IMPD
- Related Term
- clinical trial application
- clinical trial authorization
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