Potentially clinically significant gap in knowledge about the safety of a medicinal product for a specific patient population or concerning certain anticipated utilization (for instance long term use). Typical examples are children, pregnant or lactating women… Missing information is identified and monitored in the RMP and the PSUR.
Glossary
Missing Information
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Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.
Glossary
The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.
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