EFFECT OF COVID-19 ON PHARMACOVIGILANCE

Abstract

COVID-19 is one of the most disruptive events in modern history with the restriction on physical contact, travel and free movements, isolation, quarantine, and substantial clinical workload during the pandemic, traditional pharmacovigilance approaches of spontaneous reporting, and causality assessment will be more challenging. They have been unexpected opportunities recognized by innovators, researchers, and healthcare professionals. The key health authorities have released guidance for stakeholders, providing information and guidance on the conduct of clinical trials and post-marketing surveillance during the COVID-19 pandemic. To start a clinical trial a sponsor designs a research protocol. This protocol is designed according to the guidelines handed by the regulatory authority. The guidelines describe in detail how sponsors can ensure that trials or studies contain the mandatory pharmacovigilance regulations. The Pandemic affected the work of pharmacovigilance professionals, which made it work from home so it affected such processes as case submission and audits, and also it makes the biggest impact on vaccines. They are incremental changes on a large scale. The COVID-19 pandemic teaches the importance of electronic reporting, the importance of robust and responsive intelligence processes, and the need for centralized systems for submission oversight