As the final preparations are underway for the launch of the new EudraVigilance system by the European Medicines Agency (EMA), SSS International Clinical Research has revealed the steps it has taken to ensure it can effectively support pharma companies through the change.
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From 22 November, authorisation holders, pharma companies and service providers must respond to comply correctly with the required reporting obligations — all individual safety reports must be stored electronically in the EudraVigilance database. For this purpose, the EMA provides the reporting tool ‘EVWEB’, which may only be used by specially trained and accredited specialist staff. Entries are made in the new E2B (R3) format.