Pharmaceuticals / Regulatory Affairs / Postmarket Safety

EMA Updates EudraVigilance Q&As With Over 100 Questions from Sponsors

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More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22.

The EMA bills the 75-page document as a reference to be consulted before contacting the agency’s service desk, and the agency says it will issue monthly updates.

The questions cover a wide variety of topics, from logging into the reporting system to granting access to contract research organizations.

The EMA released a step-by-step guide earlier this summer to prepare drugmakers for the implementation of the new system. Authorization holders, clinical trials sponsors and national regulatory authorities must ensure their IT infrastructure is compatible before launch.

The agency plans to update stakeholders with more launch details after Oct. 1, including the anticipated downtime for the existing system and other reporting arrangements.

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