Pharmacovigilance specific requirements

Systems audits in pharmacovigilance are useful to evaluate all processes and SOPs related to pharmacovigilance and to assess the interaction with investigator sites, CRAs and related in-house personnel involved in handling safety information. QA auditors verify if the pathways and timeframes for reporting AEs and SAEs are followed and that all required recipients of such safety information are notified as needed (e.g. http //eudravigilance. emea.eu.int). SOPs and, if required, protocol-specific... 

The purpose of the safety specification is to explicitly consider the level of safety that has been demonstrated so far. It should identify what is and is not yet known about safety and the latter (i.e. what is not known) should be a major driver of the pharmacovigilance plan. The purpose of that plan is essentially to attempt to find out what is not yet known, largely because of the limitations of clinical trials. Risk minimisation plans are not invariably required - essentially they are needed when there are known or potential risks which cannot simply be managed through routine measures contained in the product information. 

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