The European Medicines Agency is set to deliver a new EudraVigilance system in 2017, which will use the E2B (R3) format, built on the ISO ICSR standard. This means that at the due time, EMA will stop using the E2B (R2) format that your single case reporting uses today. Moving from R2 to R3 is not as simple as it may sound. The structure of R3 is very different from R2, and both your processes and your safety system will be heavily impacted, leading to revised processes and an upgrade of your safety system. R3 contains new fields and some data elements have been moved from case level to event level.
The first thing to consider is that conversion between the R2 and R3 format is almost inevitable. In an interim period, from the time that EMA starts using ISO ICSR/E2B (R3) until your safety database is upgraded to deal with R3, you would need to have a clear conversion strategy and a tool to support you. EMA’s own BFC conversion tool will not offer you a full user interface to verify the complex conversion. Hence, NNIT suggests a tool that will allow the business users to view and verify the conversions.
ISO ICSR will impact your pharmacovigilance SOPs as well as your Pharmacovigilance System Master File. Moreover, retraining your safety staff will be required, and the surrounding processes in Regulatory Affairs, for example, would also need to be assessed. NNIT can assist you in these business preparation activities.
The implementation of ISO ICSR is closely linked to the implementation of ISO IDMP, which requires companies to submit substance and product information, which will be structured in IDs that the health authorities assign to each product. These IDs and product names from your future IDMP solution are to be used when creating the ICSR in your safety database; hence, a close integration with your future IDMP solution is to be planned. With current engagements in multiple IDMP system integration projects, NNIT can advise you on the right integration approach for IDMP and ICSR and for the submission in HL7 messaging standard.
Your current safety system may not be able to handle the upcoming E2B (R3)/ISO ICSR format, and eventually you may have to do an upgrade. With many years of experience in the implementation and maintenance of safety systems, NNIT knows that such an implementation requires careful planning and a strong combination of deep domain expertise and technical insight.