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GVP (Modules(M) (1.Pharmaceutical systems and quality systems, PSMF, PV…
GVP
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Definitions
Adverse events-untoward medical occurrence in a patient clinical tria subject administered a medicinal product that does not necessarily have a causal relationship with the productl
Adverse Drug Reaction-response to a medcinla product which is noxious or unitended,reasonable possibility of link between medicinal product and the reaction-may be of label,overdose,misuse,abuse and medication errors
Serious Adverse Reaction-results in death,life threatening or prolongs patient care
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Company Care Data Sheet,similar to SmPC but for company use
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PSUR-periodic safety update report,benefit:risk
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Additional monitoring,legal basis in new legislation