Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)-a company experience
Abstract Introduction In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of the dossier for initial marketing authorization of a medicinal product or with an application involving a significant change to an existing marketing authorization. A comprehensive revision of the...
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| Main Authors: | , , , , , , , |
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| Format: | Book |
| Published: |
BMC,
2022-05-01T00:00:00Z.
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| Online Access: | Connect to this object online. |
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