Author name: development

The International Conference on Harmonization of Technical Requirements for the registration of pharmaceuticals for human use, or the ICH, was formed to facilitate harmonization of requirements and procedures among member states to ensure safe, efficacious, and high-quality drugs reach the market. The founding regulatory members include the European Commission (EC) of Europe, the Food and […]

Overview Pharmacovigilance (PV) and post-market surveillance is important to capture the safety profile of a drug. The entire information on a benefit-risk ratio & safety profile is not known until or unless the drug has reached the market and been used in a larger, much wider population. Hence, a systematic approach in monitoring and evaluating

Individual Case Safety Reports (ICSRs) are a key aspect of pharmacovigilance (PV) and post-market safety surveillance as they provide crucial safety information for an approved pharmaceutical product, and a holistic view of the safety profile of the drug, including its benefit-risk profile, which is important to mitigate patient harm. The main steps involved in ICSR

A signal is information that arises from single or multiple source/s that may suggest a potential causal association between a drug and event given that the causal relationship between drug & event were previously unknown or inadequately documented. These signals are used for risk-benefit evaluation of a product and emerging safety issues that would cause

Regulatory authorities around the world conduct pharmacovigilance (PV) inspections to verify that marketing authorization holders (MAHs) and allied organizations maintain compliance with PV requirements, obligations, and relevant standards. This applies to products as well as processes. National competent authorities appoint inspectors to conduct these inspections which can be announced or unannounced. If the former, then

The integration of artificial intelligence (AI) and machine learning (ML) technology into the pharmaceutical and life sciences industry is demonstrating significant benefits on several fronts. Whether it is incorporation of real-world data into clinical investigations or automation of operations to streamline key processes, technology is driving the industry forward. Pharmacovigilance is part of the industry