Pharmacovigilance
Within the European Economic Area (EEA) life science companies are obliged to have an appropriate system of pharmacovigilance in place.
QbD Austria helps you establishing this system.
Pharmacovigilance in Europe
Companies placing pharmaceutical products on the market are obliged to have an appropriate system of pharmacovigilance in place. They have to be able to collect, prepare and submit expedited adverse drug reactions and Periodic Safety Update Reports (PSURs) to the competent authorities at the prescribed intervals.
In addition, companies are required to have at least one Qualified Person (QP) for Pharmacovigilance established within the European Economic Area (EEA). This responsibility applies to all pharmaceuticals – whether innovative drugs, generics or others. The current legislation requires all applications for new product licenses to incorporate a pharmacovigilance and risk management system.
System requirements
Your pharmacovigilance system should be able to do the following:
- Expedited reporting
- PSUR reporting
- Responding to information requests form the competent authorities
- Handling of urgent safety restrictions and safety variations
- Continuous monitoring of the safety profile of authorised medicinal products and notifying competent authorities and health professionals of changes in the risk/benefit assessments
- Meeting CHMP commitments (for centrally registered products)
- Maintaining internal audits of the pharmacovigilance system
Pharmacovigilance data should be collated and be accessible at least at one point in the EEA. Competent authorities are responsible to inspect license holders to ensure functionality of their pharmacovigilance systems through scrutiny of Standard Operating Procedures (SOPs).
- Prepare for pharmacovigilance systems audits
- Assess your SOPs
- Write PV SOPs
- Train Personnel
- Help you with PV and risk management plans
- Implement PV systems in your company
How we support you
- Prepare compliant PILs and label texts based on SmPCs
- Oversee text translation projects
- Check PILs and Labels texts for compliance
- Advice on user testing for PILs
Why opt for the QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
10+ years of experience
Benefit from our team of highly qualified consultants.
Full life cycle support
Full support from pre- to the post-marketing phase.
Global presence
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.
Customer satisfaction
Constant evaluation, transparency and clear objectives.
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