Business Case detail

Full outsourced EU Pharmacovigilance system

Project: Full outsourced EU Pharmacovigilance system

Client: Leading Generic company, North America

Summary:

This client chose Arriello to be the partner for outsourcing all of their EU Pharmacovigilance activities, both local and global.

Issues:

The client was successful nationally but wanted to expand into Europe.  However, they did not want to invest the significant amount of money and resource into building their own EU Pharmacovigilance System.    They also had products that were licensed nationally in countries in Europe where there may be a local Pharmacovigilance requirement.

The key issue was that the client understandably had limited knowledge of the European Pharmacovigilance framework and so were reliant upon us to guide them from the very beginning.

Solutions we gave: 

We began by educating our client on the requirements now and in the future so that they could plan resource and budgets.  We gave training to explain the key aspects of Pharmacovigilance in Europe so that we could ensure that they, as the Marketing Authorisation Holder (MAH) understood properly what their responsibilities would be.  We advised on local requirements for some of their products as the local requirements differed between countries. 

Conclusion

The client had no experience of EU Pharmacovigilance requirements but need to ensure they were compliant with them.  We gave them the reassurance that we managed this properly.  Moreover, because we also provided them with regulatory support, as a core part of our offering, it reduced risk for them and reassured them that we understood the whole picture, not just the Pharmacovigilance  elements.  This resulted in a successful European Health Agency inspection in January 2016.