Regulations related to pharmacovigilance in Georgia were detailed in legislation adopted in 1997 and the area sits within LEPL State Regulation Agency for Medical Activities. The system is currently inadequately managed by the State authorities and levels of under-reporting of adverse drug reactions (ADRs), particularly amongst doctors, are reported to be significant.
A poor level of understanding with regards to the importance of pharmacovigilance and an associated lack of training, perpetuate the under-reporting of ADRs.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
There is no current requirement for the marketing authorization holder (MAH) to appoint a local qualified person for pharmacovigilance (QPPV) in Georgia or, indeed, even a requirement to appoint a local contact person responsible for pharmacovigilance. This is likely to change given legislative proposals currently under review.
Indeed, within the context of what is an embryonic pharmacovigilance system in the country, and greater levels of interest shown in the market by those with embedded pharmacovigilance company systems, it is certain that the Georgian authorities will look to address this area. Innovative developments in the area will be expedited by the collaborative efforts of some foreign manufacturers currently working within the Georgian healthcare sector.
With a comprehensive understanding of current and likely future local pharmacovigilance and medical device vigilance processes and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in Georgia 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 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