For those involved in medicines and medical devices in the Serbian market developing and maintaining an approved approach to pharmacovigilance is required. The area continues to evolve in terms of the complexity of response required from the marketing authorization holder (MAH).
The pharmacovigilance activities of marketing authorization holders in Serbia are overseen by the Medicines and Medical Devices Agency (ALIMS). The MAH is expected to provide a detailed description of the pharmacovigilance system proposed to the National Pharmacovigilance Centre (NPC) within ALIMS. Any changes proposed to the SOP must be reported. All adverse reactions must be reported to the NPC. Healthcare institutions, healthcare professionals, marketing authorization holders and clinical trial sponsors are all required to report all adverse events. Patients may also report adverse events if they choose to. The Ministry of Health will conduct routine and ad-hoc pharmacovigilance inspections as they deem necessary.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
Any marketing authorization holder (MAH) in Serbia is expected to appoint a local qualified person for pharmacovigilance (QPPV).
Pharmacovigilance is a key area of focus for the national regulatory authorities. This is an area which will continue to develop in terms of both responsibility and investment for marketing authorization holders.
With a comprehensive understanding of local pharmacovigilance requirements and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in Serbia within a fully comprehensive outsourced local pharmacovigilance 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 medicines 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 (Medical Literature Monitoring) services
- System quality control checks to ensure full audit compliance
