www.productlifegroup.com Page 1 of 2 CASE STUDY ProductLife Group’s PV Expertise and Knowledge of Requirements Support EVDAS Signal Detection Expert team ensures safety signals get tracked and reported on time THE CLIENT A French generic-medicines company with a large and diverse product portfolio PROJECT SCOPE In 2018, the European Medicines Agency (EMA) established a one-year pilot programme wherein marketing authorisation holders will be required to carry out signal detection for some products in the EudraVigilance Data Analysis System (EVDAS). Products affected are those in the list of medicines under monitoring for the pilot phase. The client turned to ProductLife Group for help in meeting the new requirement for all of its products—currently nine—identified for monitoring a

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