Qualified Person for Pharmacovigilance (QPPV)
The QPPV office oversees implementation, provides direct oversight, and maintains end-to-end pharmacovigilance systems for the sponsor
The QPPV acts as the 24 hour contact point for competent authorities, supported by a backup QPPV to cover for any absences. The QPPV, along with the backup QPPV, oversees the implementation of the PV system, provides direct oversight on smooth running of the PV system, and monitors the risk-benefit status of the medicinal products to ensure safe use of the authorized products.
The QPPV responsibilities include:
- defining the process requirements for maintaining a compliant pharmacovigilance system,
- interfacing with clients and competent authorities in case of any emerging safety issues and safety concerns, and
- providing regular feedback to the client on these important elements of the pharmacovigilance system.
Our team of experienced QPPVs based in London and Germany offers separate roles such as UK-QPPV/UK-Backup QPPV and EU-QPPV/EU-Backup QPPV for end-to-end compliance with both the UK and EU regulatory requirements. The team also comprises a responsible person for EudraVigilance, supporting clients for the clinical trials in the EU.
Local QPPV, Local Contact Person, Local Responsible Person, and National Contact Person for Pharmacovigilance
Depending upon the local regulatory requirements, some countries may have specific requirements of a local contact person or locally qualified person in addition to the QPPV.
We have a well-established network of strategic local partners in 120+ countries and are currently serving actively in 30+ countries for various clients. .
This also includes national contact person service in the UK if the clients have this preference instead of appointing a separate UK QPPV.
APCER can advise you about the different roles and responsibilities of the QPPVs and local QPPVs and offers services that can accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location.
