The first edition of the European PharmacoVigilance Day took place in Milan on 30th November 2017, the event where pharmacovigilance experts, both nationally and internationally, discussed the news of EudraVigilance. We had the opportunity to show our safety database new version. Here is what emerged.
SafetyDrugs participated as unique sponsor and for the occasion, the project manager of our safety database, Mr. Carlo Ghiglione and our marketing manager, Mr. Andrea Garlanda, presented the news about SafetyDrugs 6. The new version of our pharmacovigilance product is the result of months of development, a full adjustment to the rigid parameters imposed by ICH and EMA.
We asked Mr. Ghiglione some questions:
What are the main innovations of SafetyDrugs?
“We developed the latest version of SafetyDrugs on the basis of the new ICH R3 rules regarding, for example, the multiple registrations of dosages or administration timings, the plural registration of drug correlation/reaction evaluation methods, and the null flavor management.
The MedDRA code update in ICSRs and the HL7 format for file transmission via EvWeb and Gateway have been implemented.
We also took the opportunity to make the software more user-friendly: the latest version features more intuitive graphics and new functionalities, implemented to help pharmacovigilance staff to go through with their daily operations.”
What are the functionalities?
“In order to support the company during the triage phase to establish the competence of cases received by EMA and to evaluate the priority of those to be processed, we have developed two useful and advantageous features. The first one allows to preview in an inbox all cases downloaded from EudraVigilance before the definitive import, even massive, of those evaluated to be related to the company; the second is the Smart Case Data Entry, a single window where you upload all relevant information of the case, enabling fast data entry on a single mask, and giving a clear overview of new cases in order to assess the priority.
Another idea is the message system, thanks to its possible to set up various types of messages that the user receives at his/her email address to remind him/her of the regulatory deadlines or tasks to complete.
At last, we have developed the tracking, which is like a workflow organizer where to register any annotation related to the case itself, allowing, in addition, to track follow-up requests. Each note can activate reminders that will be managed by the message system.”
What are the news about the line listing?
“For the line listing, we have studied the possibility to set the desired search filters and freely select the appropriate columns in order to extract a customized report on the user’s needs.”