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FILTRYX at a glance - the fast and reliable Triage-based solution to preselect and manage your ICSR files from Eudravigilance!

Regulatory Background

As of 22-NOV-2017 all MAHs are required to access EudraVigilance EVHUMAN ( https://eudravigilance-human.ema.europa.eu/#/ ) and to search and obtain Individual Case Safety Reports (ICSRs) for which the Marketing Authorisation Holder (MAH) cannot exclude it may concern its own product (e.g. suspected drug is only given as Generic Name without any further descriptors and/or descriptors that are equal to the MAH's product details). MAHs are obliged to process all of the ICSRs for which case ownership cannot be excluded (exclusion criteria are defined in GVP Module VI).

Limitations in EudraVigilance EVHUMAN

The Search Criteria available in the EudraVigilance download area do have remarkable limitations in terms of the MAH requirements and its own Product Portfolio (as determined via the mandatory entries in xEVMPD). Although criteria such as Seriousness and Primary Source Country are available, the search retrieves a high number of potential Individual Case Safety Reports (ICSRs) that require time consuming triage in order to determine which of the potential ICSRs are to be processed within the MAH's Drug Safety Database and which can be excluded.

Experiences with Downloads form EudraVigilance

· Following your request via the ICSR Download, you need to open each single downloaded ICSR within your search retrieved in the workspace as RTF or download the ICSR Form in order to retrieve a human readable version

· You need to assess each single downloaded potential ICSR and check whether any exclusion criteria is applicable based on the GVP exclusion criteria such as Marketing Authorisations in specific EU countries, the Marketing Status of your Products (marketed or not yet marketed), mentioned Trade Name that is not yours, Batch/Lot numbers mentioned that are not yours

· You need to document which potential ICSRs are to be processed and which can be excluded and you need to document your exclusion criteria.

· Since this process is a manual process for such a manual assessment a double-verification principle should be applied.

With an average volume of 35 potential ICSRs per day this requires approximately a resource of 1 FTA. Additionally, 1 further FTA is required to apply double-verification principle. Also, appropriate back-up is to be accounted for.

Filtryx in Day to Day Practice

Filtryx offers a solution for reliable, validated, and efficient Triage based on the customisation of your own Marketing Authorisations and Marketing Status of your Products in all concerned EU countries while at the same time providing full documentation of your search itself and the Triage Results:

· Processing of the entire batch of downloaded ICSR in one single step within less than 1 minute

· Displaying the Worldwide unique case identification number together with the EV Human number identifying the ICSR

· Automated assessment based on the customised Marketing Authorisations and Marketing Status of your Products:

· Displaying all ICSRs for which case ownership cannot be excluded and requiring to be processed in the MAH's Safety Database and the concerned suspected product substance

· Displaying the applicable exclusion criterion for all ICSRs that can be excluded and the product

· Displays Trade names and Lot/Batch numbers detailed in the potential ICSR

· Allows for adjustment of the automated assessment for specific reasons and the documentation within one step

· Real time One Click access to the HUMAN READABLE (HTML) view for each ICSR for assessment of more details, if required

· Serves as audit-proof documentation through export function as PDF document and/or in Excel format to be archived according to your business policies

· Allows for direct import of the ICSR selected for further processing into your Safety Database Application

· As it represents a validated automated process, double verification is no more necessary

 

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