Meningitis Meningitis represents a potentially life-threatening clinical syndrome characterized by inflammation of the protective membranes—known as the meninges—surrounding the brain and spinal cord. It is a condition of considerable global health concern, known to affect individuals of all age groups, with neonates, children, and immunocompromised individuals being the most susceptible. The disease may progress rapidly, … Read more
A national pharmacovigilance program is a critical initiative aimed at ensuring the safety and efficacy of medicines throughout their lifecycle, from pre-market clinical trials to post-marketing surveillance. The primary goal of such a program is to monitor, assess, and mitigate the risks associated with the use of pharmaceutical products. Establishing a comprehensive national pharmacovigilance program … Read more
Contract Research Organizations (CROs) are specialized service providers that offer comprehensive research and development (R&D) support to the pharmaceutical, biotechnology, and medical device industries. These organizations provide outsourced services to streamline the clinical trial process, from preclinical development through to post-marketing surveillance. CROs play a critical role in the development of new drugs and treatments … Read more
Establishing and operating a Drug Safety Department in a pharmaceutical company is vital for ensuring the safety and efficacy of drugs throughout their lifecycle, from preclinical development to post-marketing surveillance. The primary goal of a Drug Safety Department, also known as Pharmacovigilance, is to identify, assess, and mitigate the risks associated with the use of … Read more
Introduction to Pharmacovigilance Pharmacovigilance Programme in a Hospital: Pharmacovigilance (PV) is a critical component in ensuring the safety of medicinal products. It involves the collection, detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other drug-related problems. The primary goal of pharmacovigilance is to ensure patient safety, minimize risks, and enhance the safe … Read more
Basic drug information resources Basic drug information resources: Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is heavily reliant on information—accurate, timely, and evidence-based. The integrity of pharmacovigilance systems depends on the quality and accessibility of drug information resources. These resources can … Read more
The EudraVigilance Medicinal Product Dictionary (EVMPD), also known as the Article 57 Database, is a centralized database maintained by the European Medicines Agency (EMA). It serves as a key tool for the collection, management, and analysis of medicinal product information in the European Union (EU). The EVMPD is part of the broader EudraVigilance system, which … Read more
The WHO Drug Dictionary (WHO-DD) is an internationally recognized database of medicinal products and their related information, developed and maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization’s Collaborating Centre for International Drug Monitoring. It is primarily used in pharmacovigilance, clinical trials, and drug safety monitoring for identifying and coding medications across various … Read more
MedDRA and SMQs MedDRA and SMQs: MedDRA (Medical Dictionary for Regulatory Activities) is a globally standardized medical terminology developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It is used in regulatory submissions, clinical trials, and post-marketing surveillance to describe adverse drug reactions (ADRs), medical conditions, and therapeutic … Read more
In pharmacovigilance, drug dictionaries and coding systems play a crucial role in ensuring accurate and consistent documentation, reporting, and analysis of drug-related information, especially in the context of adverse drug reactions (ADRs). These standardized systems help in the collection, classification, and analysis of drug safety data, ensuring uniformity across regions and institutions. Coding systems facilitate … Read more
