10 Dec 2020Ended

Pharmacovigilance Audit Failures: What’s Still Going Wrong?


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10 Dec 2020


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When the current European pharmacovigilance (PV) legislation came into force in Europe in 2012, pharmaceutical companies targeting the region had to .. Read more put in place a number of formal measures to monitor the safety of products and any issues once those products were being marketed in the real world. These measures also mandate that life sciences companies must run, check and document their PV activities, so that regulating authorities can be confident that standards are being upheld and that nothing is being missed. This means pharmaceutical organisations must be able to provide evidence of strong standard operating procedures on demand, and that includes measures implemented down the supply chain. Yet, even today, companies are still struggling to fulfil their obligations, causing marketing authorisation holders (MAHs) to fail inspections, incur fines and see products withdrawn from markets. Arriello’s Vanessa Fachada and Peter Kohut discuss some of the common and potential points of vulnerability with commercial as well as safety and reputational implications, and what companies can do to reduce those risks. Arriello has been a leading provider of risk management and compliance services to the Life Sciences sector since 2008. These include Market Consultancy, Global Regulatory Affairs strategy and implementation, Full and Local Pharmacovigilance solutions, Clinical Drug Safety, and Quality and Compliance auditing and systems.

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