Why are Backward Forward Compatibility tools (BFCs) not sufficient in the wake of the new E2B(R3) format utilization ?

With the launch of the new EudraVigilance system from November 22nd 2017, the pharmaceutical industry actors are faced with the challenge of adapting their pharmacovigilance business processes and handling the ICH E2B(R3) file format as Marketing Authorisation Holders will have a legal obligation to monitor the data available in EudraVigilance, available only in E2B(R3) format.

At minima, organizations must implement conversion tool if the ICH E2B(R3) format cannot be processed in their systems. However, at AB Cube we are convinced that this solution cannot be sustainable in the long run. In fact, the use of BFCs incurs data loss linked to conversion rules that we believe hampers the good work on AEs over time.

As an example, the number of characters accepted in E2B(R3) fields is often greater than in similar E2B(R2) fields, which means that reading in a R2 compliant system a file that was imported from the EMA may give you access only to partial information regarding the case, in particular when it comes to product coding.


What is the difference between E2B(R3) compliant systems based on Backward Forward Compatibility tools (BFCs) and natively E2B(R3) compliant solutions ?

Today, numerous vigilance systems remain E2B(R3) compliant, based solely on the use of BFCs for data conversion. However, only natively compliant solutions enable users to work without any data loss linked to the use of BFCs. The data entry also needs to be deeply adapted to the new E2B(R3) format.


How did AB Cube systems evolve to get ready for simplified submission system ?

In order to adapt to the new format, AB Cube’s systems have undergone a deep metamorphosis.

In July 2016, BFC tools were implemented in all AB Cube’ SafetyEasy PV™ databases to enable import and export of E2B(R3) files.

In October 2017, AB Cube’s systems became natively E2B(R3) compliant in production through the implementation of two stages:

  • The data entry was completely redesigned to stick to the new E2B(R3) structure, enabling the use of null flavors, allowing the use of repeatable blocks inside repeatable blocks and adapting the length of fields to the new regulation. SafetyEasy PV™ became able to manage “native” E2B (R3) data entry.
  • The “save” function was updated so that all files are saved natively in E2B(R3) format instead of E2B(R2) files. This means that at the time of saving files, the information is not going through a BFC and therefore, at no time is any information lost because of the conversion.

Of course, retro compatibility has been maintained, and SafetyEasy PV™ remains completely able to Export and Import E2B(R2) ICSRs.

Early March 2018, SafetyEasy PV™ finished its transformation by successfully completing testing of its Gateway with the EMA for the transmission of native E2B(R3) files.


 Why is it the right time for you to adopt SafetyEasy?

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.

AB Cube is working on a very different model : SafetyEasy PV™ is a hosted fully evolutive and pre-validated database, delivered as a SaaS through web access. This means that all regulatory evolutions are implemented in the database 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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