PrimeVigilance has industry experience in creating efficient, compliant, multidisciplinary processes for signal detection and management, including the appropriate use of up to date statistical methodologies and data mining approaches within product safety risk management systems.
Risk management planning has to be a lifecycle activity, commencing well before entry into man and finishing only after the product is not on the market anymore.
PrimeVigilance’s experts have been developing and implementing additional risk minimisation measures (aRMMs) for products from various disease areas according to the requirements of the EU PV legislation, as part of REMSs, and for global risk minimisation approaches.
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