SafetyDrugs participated as the only sponsor of the European PharmacoVigilance Day, the event where national and international pharmacovigilance experts discussed the news about EudraVigilance. The first edition took place in Milan on 30th November 2017. For the occasion, the project manager of our safety database, Mr Carlo Ghiglione and our marketing manager, Mr Andrea Garlanda, presented SafetyDrugs 6, the new version of our pharmacovigilance product.

We interviewed Mr Garlanda for some anticipations on SafetyDrugs’ Business Intelligence.

What is the benefit of using SafetyDrugs’ Business Intelligence compared to that provided by EVDAS?
“With our Business Intelligence we can obtain the same types of EVDAS analysis, but in addition we can detail them in a much more analytical way thanks to the parameterization and the possibility to drill-down to any data of the single ICSR . In fact, the database in addition to collect information allows you to aggregate data at various levels, for example by product family, by product category, or by formulation. ”

Is it possible to perform other types of analysis?
“Yes, our Business Intelligence provides a KPI analysis: more and more companies have to monitor their own performances. We created a dedicated analysis, which is also parameterizable, to check the timeliness of submission and to control the timing of case process by deepening the analysis to the time of advancement of the case itself through the various workflow statuses.”

How is Signal Detection structured?
“In order to detect the signal, EMA recommends to use  the ROR as a disproportional indicator. We have chosen to compare also other indicators such as PRR and RR.

Other more, in addition to the total number of cases with active substance/adverse event combination, even at various levels of the MedDRA hierarchy, are highlighted the listed/unlisted, expected/unexpected, serious, fatal and from literature cases.

A very important element of the analysis is the Lower Confidence Interval95% which provides statistical evidence of the presence of a signal that the pharmacovigilant will need to deepen with qualitative analysis. The reliability of the sample is assessed by the chi-square and p-value tests.”