Pharmacovigilance has evolved significantly over the past ten years and is business critical. Ensuring the safest possible use of drugs is a company mission that is required by regulators and markets alike. It is no longer enough to be able to report in a timely manner. Drug safety processes must be 100% reliable, cost efficient, and release management capability. The aim? To create and implement an effective Lifecycle Benefit-Risk Strategy to ensure patient safety, as well as to keep your products on the market. Navitas is able to define the future of drug safety and how to get there; transforming performance and compliance by improving processes. The focus of the Pharmacovigilance and Safety function has evolved beyond compliance and into three core areas of adding value, achieving operational efficiencies and maintaining compliance. We have helped our clients in all core areas to improve their approach to Pharmacovigilance and achieve operational excellence.
Within the EU, much expectation and responsibility has been put on the shoulders of the Qualified Person for Pharmacovigilance (QPPV). The dedication and commitment to the role has, in many organisations, established good oversight of operational processes across pharmacovigilance, for example, the requirement for a PV System Master File (PSMF) to support the QPPV oversight, submission process, and operational metrics to ensure compliance to regulatory requirements and inspections.
We have taken a proactive approach to drug safety and, in 2001, we founded pvnet, a membership based network for Heads of Safety of Top 25 pharmaceutical companies. Similarly, our pvconnect forum is for Heads of Safety from mid-sized life science companies. Recent changes in global regulations has catapulted the scope of Pharmacovigilance and indeed the Heads of Safety role. This network offers access for open discussions of challenges, best practices and Thought Leadership. As the global regulations, transparency, and healthcare demands increase, the focus on patient safety and public health is becoming critical, as is the need for emerging safety organisation. We continue to work with the PV leaders to shape the future direction of pharmacovigilance.