‘One Stop’ solution for monitoring adverse drug reactions in the local medical literature – PRUDENTA
In July 2012 the European Commission has enacted a new Pharmacovigilance (PhV) legislation, which is imposing strict conditions on all owners of marketing authorizations for medicines with non-compliance to those resulting in penalties up to 10% of the annual turnover of the holding. One of the mandatory activities is mandating marketing authorization holders to monitor all local medicinal literature on a weekly basis for the medicinal product in all markets, where they are marketed.
Today such local literature monitoring is performed manually, i.e. by subscribing to journals and reading every article in print or .pdf format. Local literature monitoring in each of the EEA markets for possible adverse reaction signal detection presents a serious problem for pharmaceutical companies of all sizes.
The goal of the innovation business project is to add value to the monitoring of adverse drug reactions in the local medical literature by developing an innovative solution that will make searching possible in electronic, rather than manual, paper based way. Our target users (pharmaceutical companies around the world) will be able to increase the safety of their drugs on the market and dramatically reduce the costs of this activity, thus indirectly reducing the cost of drugs.
Prudenta offers a cloud-based solution with artificial intelligence integration and validated work-flow processes and additional quality control checks that provide electronic and instant access to published articles in local medical journals. Multiple functionalities offer to search for specific medical terms, drug names and active pharmaceutical ingredients. Search is possible in a specific country, including all or some journals, within a specific time frame and by specific keywords (e.g., aspirin). The user can instantly purchase an article from the local journal and request a translation (if such is required). Prudenta incorporates several break-through technological innovations.
PRUDENTA – innovative pharmacovigilance solution for local literature monitoring!
Prudenta is an ecosystem that makes literature searching possible in the digitalized way:
- Cloud-based solution
- Centralization of the process
- Artificial intelligence
- Validated workflow process
- Additional quality control checks
Health Europa (page 16).
Grant Agreement Number 828084-Prudenta with EUROPEAN COMMISSION Executive Agency for Small and Medium-sized Enterprises