Since its implementation in the 50s, Pharmacovigilance has evolved exponentially over time. Due to recent changes to the legislation (Good Pharmacovigilance Practices), many are now the challenges that are presented to the Pharmaceutical companies in this area. The need to have an integrated solution that allows them to identify all its responsibilities in accordance with its portfolio and ensure that these responsibilities are met continuously and prudently is absolutely crucial.
Thus, and with the growing number of pharmacovigilance requirements, PHAGECON has evolved its portfolio of services presenting nowadays an integrated solution that allows us to respond to all Pharmacovigilance Requirements from the implementation of a Full Compliant EU Pharmacovigilance System, the completion of all ongoing activities to the performance of punctual specific tasks (e.g. implementation of security measures resulting from PRAC decisions).
It is in this context that we now present our Pharmacovigilance service package and solutions that we are sure, can help your company to be totally available with this ever changing reality.
Implementing a Complete PV System
- Establishment of a EU-QPPV or Local QPPV, 24/7/365 available and with access to a Medical Doctor;
- Gap-Analysis, Elaboration and Maintenance of the PSMF and other PV SOPs;
- Establishment of the Qualified Person / Responsible Person for EudraVigilance including the xEVMPD Registration and the Establishment of the ICSR electronic Reporting;
- Elaboration of the Technical Agreements - Safety Data Exchange Agreement.
Performing all mandatory ongoing Activities
- Elaboration of CIOMS Reports;
- Perform a continuous safety profile monitoring and benefit-risk evaluation;
- Perform a Constant Signal Management;
- Elaboration of Compliance Reports;
- Perform Local and Worldwide Literature Monitoring;
- Perform a Periodic Reconciliation with the Clients;
- Pharmacovigilance in Clinical Trials.
Provide other punctual activities that might be needed
- Performance of Pharmacovigilance Audits and issuance of the applicable Audit Reports;
- Training in Pharmacovigilance;
- Perform Safety Variations;
- Install Safety Urgent Measures;
- Elaboration of Periodic Safety Update Reports;
- Elaboration of Risk Management Plans.