A Pharmacovigilance System is characterized by its structure, processes and desired outcomes. It is defined as a system used by an organization to meet its legal responsibilities in relation to PhV and designed to monitor the safety of the medicinal products and detect any change to their risk/benefit ratio. Good Pharmacovigilance Practices, ICH guidelines and various guidance documents from the US FDA, or from other regulatory bodies require that the Marketing Authorization Holder should have a robust system in place where all PhV aspects are compliant with requirements of the applicable regulatory authorities. The Pharmacovigilance System Master File (PSMF) shall describe the pharmacovigilance system and support/document its compliance with the requirements. The content of the PSMF should reflect the global availability of safety information for medicinal products authorized in the EU, presenting information on the pharmacovigilance system applied at global, regional and local levels.
Whether you need full support in preparing the PSMF or project-specific consulting, we can provide our advice and adapt to your needs. We can work with our clients to meet the pharmacovigilance requirements and keep under control the QPPV oversight.
- Preparing or maintaining an accurate and up-dated PSMF/ Collate Annexes
- Compliance metrics
- Support function for the QPPV
- Ensure full documentation of all QPPV procedures and activities
- CAPA management and tracking
- Arrange PhV training, contribute to training slides
- Track and maintain list of trained personnel and their documentation