Eudravigilance Setup and Maintenance
Dedicated team specializing in establishing and maintaining Eudravigilance systems, ensuring efficient and compliant collection, management, and reporting of adverse drug reactions. We prioritize transparency and adherence to regulatory requirements.
Comprehensive EudraVigilance Services
EudraVigilance compliance is a key regulatory requirement for marketing authorisation holders (MAH), clinical trial sponsors, and other stakeholders. The management of EudraVigilance systems includes precise setup, meticulous maintenance, and ongoing care to ensure full regulatory compliance.
At Qinecsa, we provide end-to-end EudraVigilance management services that address all aspects of system setup, SPOR registration, EV user registrations, maintenance, and compliance. Our experienced local specialists understand the regulatory aspects and can register and manage your accounts for accurate message transmission, and regulatory compliance.
Our services also extend beyond basic compliance to include effective utilisation of the EudraVigilance Data Analysis System (EVDAS). We help organisations implement structured approaches to accessing, analysing, and utilising EVDAS data.
Compliance Monitoring and Regulatory Updates
As your pharmacovigilance requirements evolve, we can monitor your systems and processes on a regular basis and adapt accordingly. For example, our team will monitor regulatory changes, changes to your pharmacovigilance organisation, product portfolios, assess their impact on your operations, and implement necessary modifications to maintain continuous compliance.
At Qinecsa, we oversee your EudraVigilance maintenance, ICSR submissions and xevmpd activities to identify and address potential compliance issues before they become regulatory concerns. Our proactive monitoring includes transmission verification, acknowledgement tracking, and systematic error resolution.
Expert team supporting the marketing authorization holder (MAH) and their QPPVs in data collection, submission, and management of Eudravigilance systems.
EVWEB Support
- Electronic reporting of SUSARs (clinical trials), and ICSRs (post marketing)
- Download and review of ICSRs for MAH products
XEVMPD Support
Updates related to SmPC, changes to the name and contact details of the QPPV, changes in the location of the PSMF, transfer of marketing authorization etc. through the article 57 maintenance submission process.
EudraVigilance Data Analysis System (EVDAS) Support
- Electronic reaction monitoring reports (eRMRs)
- Line listings of individual cases of suspected adverse reactions
- Individual case report forms
Working with Qinecsa for Your Needs
Take your pharmacovigilance organisation to the next level and let our specialists work with your team to develop and implement the best approaches for your organisational structure, product portfolio, or existing pharmacovigilance systems to manage compliance. From comprehensive outsourcing to targeted assistance with EudraVigilance challenges, we’re here to help each step of the way.
