QPPV and PSMF

Our team of 30 EU/UK Qualified Persons for Pharmacovigilance (QPPV) and their deputies, as well as over 300 local contact persons responsible for PV (LCPPV) can help you set up and maintain complex global PV systems and participate in non-routine PV activities. Their expertise spans decades of industry experience, together with in-depth knowledge of industry trends and regulations.

• Our QPPVs provide general pharmacovigilance consultancy in addition to the QPPV oversight role and can effectively advise on additional PV, risk management plan/risk minimization activities over the lifecycle of your product.
• PrimeVigilance has extensive experience in Pharmacovigilance System Master File (PSMF) and PV Safety Data Exchange Agreements (SDEA) authoring, optimization and management ensuring efficiencies in negotiating and complying with PV Agreements (PVAs).
• Our experts have assisted clients throughout all four phases of the PVA process: pre-PVA, PVA creation, implementation, as well as maintenance and termination. We believe in creating practical SDEAs/PVAs and in monitoring compliance which guarantee effective negotiations among stakeholders and timely amendments.
• We review the pharmacovigilance agreements of drug-device combination (DDC) products with suppliers to ensure that they take into consideration additional data that may need to be collected and communicated, such as device malfunctions and device-related events.

Our experienced EU QPPVs and technical experts:

• Are well-versed in developing and maintaining inspection ready PSMFs associated with one or more authorized medicinal products
• Ascertain specific regional requirements and ensure that your PV system remains fully compliant. In Europe, changes to the summary of PV system and/or changes in PSMF will be notified by our dedicated resources through the Article 57 database (XEVMPD).