MaDe (Maintenance Deadlines)
Introduction
The growing need to keep track of the procedures for the management of Dossiers and their deadlines, aimed at a better scheduling of the activities of the Regulatory Affair department, led us to propose on the market the application "MaDe" (Maintenance Deadlines).
The system is developed with the collaboration of specialists working in the field of Regulatory Affairs; therefore it results in a design constantly attentive to meet application needs, entrusting the system with the correct interpretation of the technical regulations in order to allow the user to concentrate exclusively on the professional content of his role.
Proposal
This software is therefore intended to automate as much as possible, based on the definition of a few assumptions of a general nature that the user will have to set in the start-up phase, the management of the deadlines of all the steps on which the procedures such as:
- CENT-NAT registrations (Approval - DL)
- DCP-MRP registrations (Day 0-70 - 105 - 120 - 180 - 210)
- Variations (IA, IAin, IB , II, DL, etc. )
- Renewal (Approval, DL)
- Sunset (Approval, Launch Date, Last Release Date)
- PSUR (Approval, DL)
- CEP (Approval, Supplemental Information)
- Company Expiry
- any other type of regulatory activity regulated by a timetable
At each of these procedures, in correspondence of the most significant procedural steps, it will be possible to attach documents in word or pdf format to make it even easier to consult especially in case of Deficiency.
Conclusions
To finish, we would like to underline that, from the point of view of dossiers now aimed at electronic format, MaDe allows monitoring of the timing of all regulatory activities, both by procedure and by country, updating the same with a few clicks and without the commitment of additional resources or the help of complex excel files.
In addition, using pre-set filters, provides a quick and immediate consultation and/ or extraction of the authorization situation of all drugs, whether they are charged to the company, marketed by third parties or withdrawn from the market.
