E2B(R3)
So, there we have it, the European Medicines Agency (EMA) has finally issued a statement, which confirms the date of release for the bigger, better EudraVigilance: November 22, 2017. Time to go into panic mode? Absolutely not. But, here are some of the things you should be thinking about as the deadline approaches:
Training
There is a large amount of training on the new EudraVigilance system already available on the EMA website. If you are a current Oracle Argus Safety user using a gateway, some of this is useful information, while some of it will not be relevant to the submissions that you make.
Going through the training will give you a clear understanding of what is required to be submitted and the useful tools that are available within EudraVigilance.
You will have the opportunity to test using the new XCOMP system beginning June 26, 2017.
Current Safety Database
You will need to consider if the new rules that will be required for the submission of cases to the new EudraVigilance systems will be supported by your system. If you are an Argus user, then considerations could be made to upgrade or use a backwards/forwards compatibility tool. Whatever you do, regardless of what system you use, you must consider if you need to be able to send R3 files. It would be a waste of time, money, and effort if you did not need to send the files in the first place.
If you’re using a backwards/forwards compatibility tool, considerations need to be made about what you do with the data and how you deal with this data, if you do eventually migrate to a system that can store the data in the correct tables. It could be possible that this data would require, essentially, a “mini-migration.” If a migration tool is used, will that need to be validated? How much testing is required? Is this effort, time-wise, fruitless if an upgrade takes the same amount of time? What would the total cost of this effort be?
If it is decided to upgrade, there are many considerations, again. How much will it cost? How long will the upgrade take? What version do I need to upgrade too?
Also, if you are an Argus user, any automated business rules you may have with European Health Authorities would need to be simplified for the new EudraVigilance system.
Business Processes
Finally, what business processes will be affected with the new system coming online? Do SOPs need to be updated? How about your Safety Data Exchange Agreements (SDEAs)? Does your current workflow for cases adapt to the changes? How are the new data analysis capabilities of EudraVigilance incorporated with the current internal system?
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If you have any questions about EudraVigilance or our consulting and technology services, please let us know.
