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Pharmacovigilance Plan based on the NormsThe structure of a pharmacovigilance plan is the most basic outline.
This plan is customized and modified based on the safety specifications and the issues identified with a particular drug.Routine pharmacovigilance procedures are conducted on all types of drugs.
This routine generally includes methods and systems that guarantee that information about all the suspected negative effects reported are initially collected and later collated in an efficient manner.
Routine procedures also include the formation of reports for the regulatory authorities.
This includes signal detection, issue evaluation, updating of the labels, and liaison with the authorities.
The local regulations determine the rest.A plan of action for the safety issues is presented and justified based on the objective of the proposed action of the drug.