Impact

Recent trends have underscored the importance of managing regulatory risk in the pharma industry.  US FDA (U.S. Food and Drug Administration) notifies the manufacturer when finds regulation violations. This notification is often in the form of warning letter.

This is the main SPuMoNI contribution: aiding companies to succeed from the commercial and regulatory point of view by reducing and controlling the regulatory exposure in such a way that they are able to develop a central competence in the management of these risks, converting managing risk in a sustainable competitive advantage.

To face the risks that the business involves, i.e. the market, financial and regulatory, they will participate in pilot field studies conducted by IDA with the potential leverage of other FAREVA manufacturing facilities in France and Germany. SPuMoNI will scale up a multi-stakeholder understanding and commitment to maximizing health data quality, for all primary and secondary use purposes, establishing strong collaborations with the iHD project and EFPIA. A key point for the adoption of the outcome of the project beyond the duration of the project and in different countries is that IDA and its parent company, FAREVA, manufacture medicines for big pharma companies across and outside Europe, corresponding to significant dissemination avenues for SPuMoNI results.

At the end of the day, if the manufacturing of the medicines that Europeans, and indeed world citizens, are taking every day is improved in compliance with the pertinent regulations, SPuMoNI will make a substantial improvement in patient safety and, ultimately, in quality of life.