Final preparations for the launch of the new EudraVigilance system by the European Medicines Agency (EMA) for a smooth start on November 22, 2017 – authorization holders, pharmaceutical companies and service providers must respond in order to comply correctly with the required reporting obligations.
Germering near Munich, November 20, 2017. SSS International Clinical Research GmbH (SSS), a contract research organisation for clinical trials, is supporting pharmaceutical companies to correctly report safety relevant information after the update of the EudraVigilance database. Comprehensively trained specialists, registered at the EMA, are responsible for the compliant reporting thereby providing security to the authorization holder or sponsor of clinical trials. Start-up companies in the biotechnology and other medical sectors, in particular, will save time and resources to concentrate on their core business.
As early as 2010, the EU Regulation No. 1235/2010 kicked off a reorientation in drug safety. The aim was and is to create more transparency with standardized approval procedures and to provide faster and better information about drug safety. This November, the transitional period for the new version of the pan-European database ends. From November 22, 2017, 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.
Concentrated Knowhow for Pharmacovigilance
SSS International Clinical Research reacts to this new regulation and strengthens its competence in the pharmacovigilance area. For ten years, an experienced team of pharmacologists, biologists and physicians have been established at the Romanian site in Timisoara. In addition to local clinical trials for clients in the pharmaceutical and biotechnology industries, drug safety responsibilities have been pooled for years at this site. The new European standards required 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. 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.” reports Dr. Dan Sabou, Managing Director Romania, SSS International Clinical Research.
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 specialized team in Romania has a key role to play for the pharmacovigilance services we offer.”