Introduction The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a globally recognized and influential organization that plays a central role in the harmonization of pharmaceutical regulations and standards across different regions. Founded in 1990, the ICH was created as a collaborative effort among the regulatory authorities and the … Read more
Safety Data Generation in Drug Development: Ensuring the safety of pharmaceutical products is a foundational objective in drug development. Drug safety, also known as pharmacovigilance, refers to the science and activities concerned with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Safety data are generated across a continuum of … Read more
IntroductionPharmacovigilance (PV) is the science dedicated to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. At its core, pharmacovigilance relies on robust communication pathways to ensure that safety data flows efficiently from source to stakeholder. Whether it’s sharing case reports with regulatory agencies, briefing business partners on risk management strategies, counseling … Read more
Comparative Observational Studies: Observational studies hold a central and indispensable place in the realm of clinical research and epidemiology. Unlike experimental designs such as randomized controlled trials (RCTs), where researchers deliberately assign exposures to study their effects on outcomes, observational studies passively observe individuals in real-world settings without intervention. This approach reflects actual scenarios and … Read more
While passive surveillance relies on spontaneous or voluntary reporting, active surveillance involves proactive, organized, and systematic efforts to detect, collect, and assess information about adverse drug reactions (ADRs) or vaccine-related events. It is considered more reliable for assessing causality, estimating incidence rates, and evaluating drug safety in specific populations. Active Surveillance Active surveillance is critical … Read more
Passive Surveillance in Pharmacovigilance: Pharmacovigilance plays a pivotal role in ensuring the safety of medicinal products, including vaccines, throughout their life cycle. Among the various techniques employed in pharmacovigilance, passive surveillance remains one of the most extensively used due to its feasibility, broad scope, and utility in the early detection of safety signals. Understanding Passive … Read more
1. Introduction of Vaccine Safety Surveillance Vaccine Safety Surveillance: Vaccines represent one of the most significant medical achievements in human history, having drastically reduced morbidity and mortality associated with infectious diseases. However, like all medical interventions, vaccines are not completely devoid of risks. Ensuring their safety is a crucial component of public health, particularly in … 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
