by Anna Kamocsai | Jan 6, 2025 | Pharmacovigilance
What is the Pharmacovigilance Audit process? In healthcare, ensuring patient safety through the integrity examination and evaluation of pharmacovigilance systems, are priorities. This is where Pharmacovigilance (PV) Audits come into the spotlight. In an industry... by Anna Kamocsai | Feb 6, 2024 | Pharmacovigilance
It is fascinating to observe how the realities of war have affected the way in which the literature monitoring of Pharmacovigilance is carried out in Ukraine. The need for continuous monitoring of drug safety in a country at war, and the ability to adapt to the... by Nick | Oct 9, 2023 | Pharmacovigilance
In constantly evolving drug safety systems, introducing new functionalities and added features are pivotal moments that demand scrutiny. With each system upgrade, a whirlwind of queries is involved – should we validate? If yes, how extensively? And, importantly,... by Nick | Sep 1, 2023 | Pharmacovigilance
CSV & Risk Management Pharmacovigilance stands as a guardian in drug development and monitoring, ensuring that medicines remain safe and effective throughout their lifecycle. But behind this sentinel lies a complex web of systems, processes, and regulations, each... by Nick | Aug 5, 2023 | Pharmacovigilance
Individual Case Safety Reports or ICSR in Pharmacovigilance are essential tools, ensuring pharmaceutical products’ ongoing safety and efficacy, as well as continuous safety of patients. If you’ve ever wondered how adverse drug reactions are detected,... by Nick | Jun 14, 2023 | Pharmacovigilance
The pharmaceutical industry constantly evolves, with new drugs being developed and approved daily. One critical aspect of ensuring the safety and efficacy of these medications is the periodic assessment of their risk-benefit profile. Enter Periodic Safety Update...