AB Cube completed testing with EMA for E2B (R3) files Import/Export and Gateway submission.

On 6th march 2018 AB Cube successfully completed testing of the E2B (R3) import and export functions and the Gateway of its cloud based SafetyEasy PV™  drug safety database. AB Cube therefore becomes the first pharmacovigilance software editor to provide a tested E2B (R3) native drug safety database to all its customers. AB Cube’s customers can now contact qattesting@ema.europa.eu to confirm that step 5b can be performed without the need for confirmation by the Agency. Learn More…

With the implementation of the new EudraVigilance system on 22nd November 2017, AB Cube’s SafetyEasy PV™ safety database undertook a deep transformation to become fully E2B (R3) native. This means that E2B (R3) files are now natively imported and exported from the database, without undergoing any transformation in a Backward Forward Conversion tool. Native import of E2B (R3) files was made possible on 22nd November 2017, shortly followed by Native export of E2B (R3) files in December 2017.

“While the EMA still allows the use of Backward Forward Conversion tools, we believe that this approach cannot work in the long run. Investing in BFC tools brings about heavy costs and extra work, for a solution that can be only temporary and unsatisfactory. In fact, the conversion of E2B (R3) files into E2B (R2) files induces information loss that hampers good pharmacovigilance practice. We are very proud of bringing a native E2B (R3) to 100% of our customers which enables them to benefit to the fullest from the advantages brought about by the new submission format” said Matthieu Doresse, CEO of AB Cube. Learn More…

AB Cube’s pioneer model enables us to provide latest adaptations to regulation changes to all of our customers at once. While for many safety platforms users, regulation changes mean extra costs to upgrade their solutions to a new version and complexity to find temporary solutions before the upgrade is performed, all regulatory evolutions are implemented in SafetyEasy PV™ ahead of regulation changes, at no cost for AB Cube’s clients. AB Cube is able to work on this model thanks to its unique cloud architecture in which all AB Cube clients use the same version of the software, which has been designed to be extremely flexible and adapt the needs of all organizations, from multinational pharmaceutical groups to biotechs.

At the time of integrating BFCs to their vigilance solutions, AB Cube strongly recommends pharmaceutical industry to consider moving one step ahead directly and choosing natively R3 compliant solutions. Moreover, E2B(R3) is not the last regulatory change to expect. In the coming years, new regulations will be put in place in particular for processing of clinical trials safety information, and after 2020 with the implementation of IDMP. AB Cube guarantees you an evolutive solution, that will help you adapt to these changes without delay and extra-cost.

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