PHARMACOVIGILANCE AND SAFETY SERVICES
Galena Pharma has an in-house pharmacovigilance system for medicinal products audited by Fimea and a post-market surveillance system (PMS) for medical devices audited by a notified body.
With a pharmacovigilance and safety system, we take responsibility for continuous assessment of the risk-benefit ratio of pharmaceuticals that are under development or already on the market. If necessary, we can take the appropriate measures to safeguard public health.
Our pharmacovigilance system enables us to act on behalf of the client as the holder of marketing authorisation for pharmaceuticals.
The PMS system enables us to act on behalf of the client as a legal manufacturer of a medical device.
OUR SERVICES INCLUDE:
- Acting as the EU Qualified Person Responsible for Pharmacovigilance (EU QPPV)
- Acting as a Person Responsible for Regulatory Compliance (PRRC) of medical devices
- Preparing, reviewing and submitting Periodic Safety Update Reports (PSURs), Clinical Assessment Reports (CERs), PMS and Post-Market Clinical Follow-up (PMCF) plans and reports
- Preparing and maintaining the master file of the pharmacovigilance and device safety system
- Handling adverse events and hazards
- Exporting product information to the EudraVigilance database and Eudamed
- Electronic reporting of adverse reactions and events to the EudraVigilance database and Eudamed
- Managing reconsolidation processes
- Translating pharmacovigilance and device safety documentation
- Performing literature follow-up for pharmaceuticals and medical devices
- Managing drug and safety signal detection and evaluation processes
- Performing risk management and risk minimization measures
For more information, contact our expert or fill the contact form.