We have asked to SafetyDrugs Project Manager, Mr. Carlo Ghiglione, to share with us how the software, developed to manage pharmacovigilance, will comply with the ICH R3 directives.
Here are his replies to Francesca Brigneti of the marketing team.
Which impact will the new norms have on the routine activities of the people who work in pharmacovigilance?
The habits will not be overturned, but quite the contrary. The few changes mainly concern the insertion of some data in the case, for example, the obligation to justify a field left empty (null flavor) or the time and the time zone of the adverse event.
What was the work of software adjustment focused on?
To simplify the switch to the new rules, our development team has reconsidered the database design. SafetyDrugs will have a more powerful engine for a smoother experience. This is the reason why everyone who uses SafetyDrugs can choose the most convenient moment to align with the new requirements.
However, the dialogue with those whom works according to the ICH R2 will always be possible, importing and exporting cases in XML format and/or in the new HL7 format.
How will the transition run?
The inconvenience for our clients will be reduced to the minimum. In a few days, they will be completely able to work with the new rules. The process includes a new test environment set up for the data conversion validation. Then the client will start working in a completely compliant to the ICH R3 environment.