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Tuberculosis Tuberculosis (TB) is a chronic infectious disease caused by the Mycobacterium tuberculosis complex, primarily affecting the lungs but capable of involving almost any organ system in the body. TB has been one of humanity’s deadliest diseases for centuries and continues to remain a leading cause of morbidity and mortality worldwide, especially in low- and … Read more
Leprosy Leprosy, also known as Hansen’s disease, is a chronic infectious disease that primarily affects the skin, peripheral nerves, mucosa of the upper respiratory tract, and eyes. Caused by the bacterium Mycobacterium leprae, it is one of the oldest recorded diseases in human history and carries a significant social stigma, largely due to disfigurement and … Read more
Typhoid Fever Typhoid fever, also known simply as typhoid, is a systemic infectious disease caused by the bacterium Salmonella enterica serovar Typhi (S. Typhi). It is a life-threatening illness primarily affecting the gastrointestinal tract and can lead to severe complications if not diagnosed and treated in time. The disease remains a major public health challenge … Read more
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
