EMA postpones the entry into force of the ICH R3 regulations: this is what emerged at the round table organized by Asgenia where, to the users of SafetyDrugs, Max Application explained the migration to ICH R3.
The postponement was expected for some time and now it is official. The ICH R3 entry into force, initially scheduled for July 2017, has been delayed to November 2017. The news was breaking by EMA, in concomitance with the roundtable of last 22 June organized by Asgenia in Assago (Milan). There were present the major Italian generic drugs producers, hosted, for the occasion, in Teva Italia headquarters.
The four-month delay arises from the European agency need to adequately test the digital platform in view of the data traffic increase.
Among the speakers of the day there were present Carlo Ghiglione and Andrea Garlanda too, respectively project manager and marketing manager of Max Application, company developer of SafetyDrugs, who have explained the necessary steps for the migration to the new ICH rules.
In detail here’s the sequence of actions suggested to pharmacovigilance software users:
1) Creation of a test environment compliant to ICH R3
- Copy and conversion of the safety database ICH R2
- Training based on the converted data
- Software validation
2) Creation of a production environment compliant to ICH R3
- Start-up date definition
- Copy and conversion of the safety database ICH R2 in the production environment
- Validation of the migration process
3) Operative start-up
As stated by the different speakers during the day, the thorough adherence to the above listed operations preserves from penalties provided. Moreover it is given the opportunity to reap the benefits of the innovations introduced by ICH R3, as the new HL7 standard compliancy for the healthcare global communication.