Clinical Records in Pharmacovigilance: An Active Monitoring Program in the Context of a Pandemic

Pharmacovigilance plays a major role before and after the drug development process. In this article, a detailed explanation of the pharmacovigilance actives and the benefit-risk evaluation has been discussed. Every drug or medicinal product undergoes clinical phases when coming to the market approval, and they have a benefit-risk ratio of…

It is well known that prescription drugs can result in a myriad of ADRs, including psychiatric ADRs. Psychiatric effects of drugs can impact sensorium, attention, concentration, memory, and higher cognitive functions resulting in distressing physical illness and psychiatric consultation. Generally, in regards to psychiatric effects associated with drug therapy, complications…

Pharmaceutical legislation provides a legal framework, to ensure the availability of acceptably safe, effective enhancement and high-quality medicines to patients. Within this framework, marketing authorization holders (MAHs) are requested to establish and maintain pharmacovigilance (PV) systems. These systems should be capable of detecting, assessing, understanding, and preventing adverse effects or…

During the clinical trials of an investigational drug, timely evaluation of safety data is crucial to the ongoing assessment of risk to trial subjects. It is also important to inform health authorities, ethics committees and IRB at regular intervals about the results of analyses risk and the evolving safety profile…