For those involved in medicines and medical devices in the Slovenian market developing and maintaining an approved approach to pharmacovigilance and medical device vigilance is vital. A comprehensive response to pharmacovigilance is required by the Slovenian authorities, in line with EU legislation and requirements.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
Although it is not mandatory for the marketing authorization holder (MAH) to have a qualified person responsible for pharmacovigilance (QPPV) located in Slovenia, the Public Agency for Medicinal Products and Medical Devices (JAZMP) has the power to request this.
JAZMP has responsibility for overseeing the pharmacovigilance activities of all MAHs in the country, with pharmacovigilance processes specified by the relevant EU legislation in addition to the Slovenian Medicinal Products Act. JAZMP expects all MAHs to follow Good Pharmacovigilance Practices. All adverse events should be reported within the procedures associated with the EudraVigilance database.
The MAH must obtain consent from JAZMP with regards to the content and communication plan prior to any Direct Healthcare Professional Communication (DHPC) activity.
With a comprehensive understanding of local pharmacovigilance requirements and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in Slovenia within a fully comprehensive outsourced local pharmacovigilance services solution.
A FULLY COMPREHENSIVE SOLUTION FOR LOCAL PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for local pharmacovigilance activities for clients unable or unwilling to invest in the development of relevant systems on their own account.
With proven success over two decades, Grove has developed a comprehensive package which meets the needs of both its individual clients and the relevant local authorities. The service is continually developed to ensure it remains relevant and is bespoke to the client in question.
For those involved in pharmaceuticals/medicines/drugs/medicinal products and medical devices, the pharmacovigilance service package comprises:
- Full-time (24/7) service of a local qualified pharmacovigilance person, QPPV
- 24-hour cover for adverse event reporting
- In-time case reporting
- End-to-end processing of safety information
- Production of PSUR (periodic safety update reports)
- Production of individual case study reports
- Access, as and when appropriate, to local healthcare professionals and authorities
- MLM, local Medical Literature Monitoring services
- System quality control checks to ensure full audit compliance