QPPV, local QPPV and named safety contact
QPPV (Qualified Person Responsible for Pharmacovigilance)
Within the EU, each marketing authorisation holder (MAH) of human or herbal medicinal products must have at their disposal a single point of contact, with a deputy, who is available 24/7 to act as the Qualified Person for Pharmacovigilance (QPPV). The QPPV must be experienced in all aspects of pharmacovigilance and reside and work within the European Economic Area (EEA).
A comprehensive pharmacovigilance system requires fluent communication between stakeholders, good interaction between processes, a robust quality management system with record management and efficient, proactive oversight by an experienced QPPV. With Medfiles’ competent QPPVs and deputy QPPVs, you can be sure that your pharmacovigilance system fulfils the requirements of Directive 2001/83/EC and the Good Vigilance Practice (GVP) guidelines. In addition to QPPV services, you can also outsource the set-up and maintenance of the entire pharmacovigilance system or just some of your pharmacovigilance activities to Medfiles.
Our QPPVs have range of experience as safety experts with additional training on quality assurance, data integrity and data validation.
Local QPPV and Local safety contact
While the requirements and responsibilities of an EU QPPV are specified in the EU legislation, local QPPVs and safety contacts are subject to the national legislation in each country. When you need qualified and experienced local QPPVs and safety contacts in the applicable European territories, including the UK, we can help you with our extensive regulatory and pharmacovigilance partner network. The selected partners are qualified and audited by Medfiles’ vendor management operations.
Through Medfiles, communicating with the national competent authorities is easy, and Medfiles’ experts are happy to advice you on local pharmacovigilance requirements. By continuously monitoring local regulations, our experts are always up to date with the current legislation and any upcoming changes.