With the introduction of ICH R3 rules, the definition of the data used in the electronic transmission of different kinds of ICSRs has been standardized, independetly from the source or the destination.
SafetyDrugs, the pharmacovigilance software made in Italy, is preparing itself for the new parameters.
With the new version 6, in fact, many news will arrive to make easier the work of people who every day manage the registration and the analysis of the cases coming from drugs adverse events.
In accordance to the ICH R3 rules, among the other news, we introduced the HL7 format for file transmission, that it replaces the XML format; we implemented the multi-byte international characters set, that allows to report the original words in the native language used by the reporter; and we provided the management of the medicinal products unique identification (MPID) new codes.
The SafetyDrugs news, however, are not only about the adaptations to the ICH R3 rules, we have done more! Listening to the opinions and the suggestions of our customers, collaborators and consultants, we achieved an important goal: create a better version of SafetyDrugs.
Some of the new functionalities are: the introduction of the gateway, that allows direct case transmission to EMA, FDA and all Regulatory Authorities; the implementation of an automatic multilanguage translator, in order to speed up the translation of reporters original texts; the introduction of a tool which highlights the regulatory, or not, cases deadline.
These are just some of the news features of SafetyDrugs 6.
We showed the new version of our pharmacovigilance software made in Italy in occasion of the 57th Symposium AFI .
Contact us to have additional info about SafetyDrugs 6.