News And Events

EMA and FDA To Start Monthly Transatlantic Drug Safety Teleconferences

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced plans to hold new monthly drug safety teleconferences to discuss drug safety issues that impact both agencies.

The conversations will focus on information exchange rather than policy development. Teleconferences will be attended by 5 or 6 EMA staff members, and the same number of FDA employees, as well as members of the Pharmacovigilance Risk Assessment Committee (PRAC), established in Europe in 2012.

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