Pharmacovigilance at Eignapharma

Eignapharma will guide you in the process of achieving a healthy and compliant Pharmacovigilance system, whether in a European framework or other International settings. Our experienced team has strong knowledge of International drug safety regulations and a strong commitment to working with high Quality standards. We carefully follow up the future direction of Pharmacovigilance maintaining permanent contact with leading experts and regulatory agents. This allows us to constantly plan in advance any upcoming changes, thus better protecting your interests. Our activities cover the whole range of requirements during the MA life cycle: • In preparation of MA Application dossiers: - EU QPPV - Appointment of European Qualified Person for Pharmacovigilance - PSMF - Authoring and maintenance of the PV System Master File - RMP - Authoring and maintenance of the Risk Management Plan • Services added once the dossier has been submitted (MA Applicants): - Global scientific literature screening - Local scientific literature screening - Quality management system - Authoring and maintenance of Standard Operating Procedures (SOPs) - GVP audits • Services added upon approval (MA Holders): - LPPV - Appointment of Local Person for Pharmacovigilance - XEVMDP maintenance - SDEAs and contractual agreements - Regulatory & Pharmacovigilance intelligence - Signal Management including EVDAS activities as applicable - PSUR - Authoring and submission to the EMA PSUR Repository - PV training - Periodic reconciliations - General Data Protection Regulation (GDPR) - Medical information services • Services added upon Marketing launch of the products: - ICSR management & database/tracking tool - ICSR Reporting to the Health Authorities - Collection of Product Quality Complaints - Out-of-hours service for collection of product related safety data Contact us for more information.