Those involved in medicines/medicinal products and medical devices in Romania are expected to follow the guidelines on good pharmacovigilance practices (GVP).
Beyond the need to meet expected pharmacovigilance-related standards as stipulated by the EU, the MAH might be asked to undertake post-authorization studies related to the safety or efficacy of a particular product. Currently, all pharmacovigilance and medical device vigilance activities must be undertaken within the context of the Personal Data Processing Law which states that personal data related to health cannot be processed without the data subject’s specific consent.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
The MAH may be asked by the National Agency for Medicines and Medical Devices to appoint a pharmacovigilance contact person in Romania, who would report to the EU-QPPV. NAMMD is the National Competent Authority (NCA) with regards to pharmacovigilance.
It is expected that where a local contact pharmacovigilance person is appointed, this person would be able to conduct local literature monitoring, take responsibility for case processing and distribute DHCPs, for example, in line with GVP guidelines.
With a comprehensive understanding of local pharmacovigilance processes and local pharmacovigilance contacts Grove provides a range of pharmacovigilance activities in Romania within a fully comprehensive outsourced local pharmacovigilance services solution.
A FULLY COMPREHENSIVE SOLUTION FOR PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for local pharmacovigilance services 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 (Medical Literature Monitoring) services
- Pharmacovigilance training for the client’s local sales force
- System quality control checks to ensure full audit compliance
