Q: What is requirement to perform an audit? A: The marketing authorisation holder in the EU is required to perform regular risk-based audits of their pharmacovigilance system [DIR Art 104(2)]. The dates and results of audits and follow-up audits shall be documented. Q: What is Audit strategy? A: The audit strategy is a high level …
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Q: What is need of Pharmacovigilance system master file (PSMF) in Pharmacovigilance? A: The legal requirement for marketing authorisation holders to maintain and make available upon request a pharmacovigilance system master file (PSMF) was introduced by Directive 2010/84/EU. Q: Location of PSMF? A: The PSMF shall be located Either at the site in the EU …
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GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course ICSRs Handling (Module VI) EMEA …
GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course Signal Management (Module IX) EMEA …
