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Industry/EMA Discuss Early Concerns Over EU’s Safety Signal Reporting Pilot

 
• By Ian Schofield

Industry representatives have raised some issues around the EU’s pilot program for drug safety signal monitoring and reporting via the revamped EudraVigilance system.

Safety First
The EMA and industry are trialing new safety signal requirements

An early assessment of the EU’s pilot program for monitoring and reporting drug safety information has shown that the initiative has pharmaceutical industry backing but that companies have concerns about how it is operating.

At a meeting with the European Medicines Agency in March, industry representatives said that they supported the proposed metrics for evaluating the pilot and were happy to collaborate on data...

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