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.
As such, these new European standards require additional measures to qualify and accredit the technical staff. “During the last months, we completed the comprehensive training curriculum recommended by the EMA and are now in the best possible position,” reports Dr Dan Sabou, managing director Romania, SSS International Clinical Research. “In addition, we have accredited our EMA staff to EudraVigilance, so we can continue to provide our clients with expert and comprehensive support in the area of drug safety.”
Other regulations of clinical research are also under continuous development. Dr Michael Sigmund, owner and managing director of the German parent company of SSS, has been observing the changes in the regulatory environment for years: “In order to keep up with the demands, a constant and up-to-date training of our employees is of the utmost importance. Developing and bundling competencies is essential to us in order to provide our customers with reliable, complete and compliant services. Our specialised team in Romania has a key role to play for the pharmacovigilance services we offer.”
SSS works with biotech, medtech, diagnostics and pharmaceutical companies throughout Europe as a clinical contract research institute (CRO).