Latest Drug Safety Updates & Expert Articles

The Global Shortage of Pharmacovigilance Specialists: Why It Matters and What Can Be Done? In today’s world, ensuring the safety of medicines is more important than ever. Whether it’s a life-saving cancer drug or an everyday pain reliever, patients need to know the medicines they take are safe. That’s where pharmacovigilance specialists come in—they’re the

History of QPPV and LCPPV: Evolution of Pharmacovigilance Roles Qualified Person for Pharmacovigilance (QPPV) and Local Contact Person for Pharmacovigilance (LCPPV) are pivotal roles in pharmacovigilance systems, aimed at ensuring drug safety. Their emergence is closely tied to the development of regulatory frameworks in the pharmaceutical industry. Below is a concise history of the origins

Types of Pharmacovigilance encompass various approaches to monitoring the safety and efficacy of medicinal products throughout their lifecycle. These methods ensure that potential risks associated with drugs are identified, assessed, and mitigated effectively, safeguarding public health. From clinical trial monitoring to post-marketing surveillance, each type plays a crucial role in maintaining drug safety and regulatory

IntroductionCompliance with pharmacovigilance (PV) regulations is a cornerstone of ensuring drug safety and maintaining trust with regulatory authorities. This expanded checklist provides detailed, actionable steps to set up and manage a robust PV system, ensuring adherence to global standards while protecting patients. Checklist for PV System Setup Checklist for Case Processing Checklist for Risk Management

Understanding Pharmacovigilance Courses: A Gateway to Drug Safety and Public Health Pursuing a pharmacovigilance courses is an excellent way for healthcare professionals, scientists, and aspiring students to develop the expertise needed for a career in this vital field. What Are Pharmacovigilance Courses? Pharmacovigilance courses are specialized training programs designed to educate participants on various aspects

The World Drug Safety Congress: A Platform for Advancing Pharmacovigilance and Drug Safety The World Drug Safety Congress (WDSC) is a globally recognized event that brings together stakeholders in pharmacovigilance, regulatory sciences, and drug safety to discuss the latest developments and challenges in the field. This article explores the Congress’s role in shaping drug safety

Semaglutide, a GLP-1 receptor agonist, has shown significant efficacy in managing type 2 diabetes, obesity, and associated cardiovascular risks. However, Semaglutide safety profile necessitates careful evaluation, supported by extensive clinical trials and post-marketing studies. Adverse Effects Cardiovascular and Metabolic Benefits In trials such as STEP-HFpEF, semaglutide demonstrated substantial benefits in heart failure with preserved ejection

Introduction Pharmacovigilance plays a pivotal role in safeguarding public health by monitoring the medicines safety. While passive pharmacovigilance relies on voluntary reporting of adverse drug reactions (ADRs), active pharmacovigilance adopts a proactive approach to identify, assess, and mitigate risks associated with medicinal products. This article explores the concept of active pharmacovigilance, its methodologies, benefits, and

Pharmacovigilance in Belarus: Changes in 2024, Challenges, and Prospects Introduction Pharmacovigilance is a critical element in ensuring drug safety and monitoring adverse drug reactions (ADRs). In Belarus, pharmacovigilance has undergone significant changes in 2024, bringing it closer in line with international standards, particularly those set by the Eurasian Economic Union (EAEU). This article explores the

Local QPPV (LQPPV) in CIS, EAEU, Georgia, and Ukraine: Ensuring Regional Pharmacovigilance Compliance Pharmacovigilance (PV) plays a vital role in ensuring the safety of medicines globally. In the Commonwealth of Independent States (CIS), the Eurasian Economic Union (EAEU), Georgia, and Ukraine, the regulatory landscape emphasizes the need for a Local Qualified Person for Pharmacovigilance (LQPPV).

Pharmacovigilance in Tajikistan: Current Status, Challenges, and Prospects in 2024 AbstractPharmacovigilance (PV), the monitoring of adverse drug reactions (ADRs) and ensuring drug safety, is a critical component of healthcare systems globally. In Tajikistan, a low- to middle-income country in Central Asia, pharmacovigilance is at an early stage of development. This article explores the current status

Pharmacovigilance in Uzbekistan: Current Trends, Challenges, and Prospects for 2024 AbstractPharmacovigilance (PV), the science of monitoring the safety of medicines and preventing adverse drug reactions (ADRs), is crucial for ensuring public health. In Uzbekistan, pharmacovigilance has evolved significantly, driven by healthcare reforms and regulatory advancements. This article explores the current state of pharmacovigilance in Uzbekistan,

Pharmacovigilance in Georgia: Progress, Challenges, and Future Directions AbstractPharmacovigilance (PV) ensures the safety of pharmaceutical products by monitoring adverse drug reactions (ADRs) and ensuring regulatory compliance. In Georgia, the PV system is evolving through international collaboration, adherence to global standards, and increasing public awareness. This article explores the current state of pharmacovigilance in Georgia, highlighting

Pharmacovigilance in Turkmenistan: Status, Challenges, and Prospects Pharmacovigilance (PV) is a crucial component of healthcare systems, ensuring the safety of pharmaceuticals by monitoring adverse drug reactions (ADRs) and preventing drug-related harm. Pharmacovigilance in Turkmenistan, has been a growing priority, particularly in recent years as the pharmaceutical market expands and healthcare reforms take place. However, several

Pharmacovigilance in Kyrgyzstan: Status, Challenges, and Future Directions AbstractPharmacovigilance (PV) is critical for ensuring the safety of medicines and protecting public health by monitoring adverse drug reactions (ADRs). In Kyrgyzstan, as in many countries in Central Asia, pharmacovigilance systems are developing, facing challenges such as limited resources, underreporting, and insufficient training. However, recent efforts, including

Pharmacovigilance in Ukraine: Current Status, Challenges, and Future Directions AbstractPharmacovigilance (PV) plays a crucial role in ensuring the safety and efficacy of medicines, protecting public health by monitoring adverse drug reactions (ADRs) and medication errors. In Ukraine, the field of pharmacovigilance has evolved significantly in recent years, influenced by both domestic reforms and international standards.

Pharmacovigilance in Kazakhstan: Progress, and Future Directions Pharmacovigilance, which involves monitoring the safety of drugs on the market and identifying adverse drug reactions (ADRs), plays a crucial role in protecting public health. In Kazakhstan, the pharmacovigilance system has evolved over the past decade, driven by regulatory reforms, improved healthcare infrastructure, and international collaboration. As the

Pharmacovigilance in Azerbaijan: Current Status, Challenge and Future Prospects Pharmacovigilance is an essential component of the healthcare system that aims to ensure the safety and efficacy of medications, particularly in post-market settings. In Azerbaijan, the importance of pharmacovigilance has been increasingly recognized as the country aligns itself with international standards and strives to modernize its

The Pharmacovigilance in the CIS, EAEU: Regulatory Frameworks, Challenges, and Future Directions Pharmacovigilance (PV) is essential to ensuring the safety of medicinal products after they are introduced to the market, as it helps identify adverse drug reactions (ADRs) and other safety issues that may not have been observed in pre-market clinical trials. The Commonwealth of

A Critical Interface in Drug Safety and Compliance Pharmacovigilance regulatory affairs represent the intersection between pharmacovigilance, which focuses on monitoring the safety of medicines, and the regulatory framework that governs drug approval and market authorization. This critical field ensures that pharmaceutical companies comply with national and international drug safety regulations while safeguarding public health. The

CIOMS in Pharmacovigilance: Advancing Global Drug Safety Practices Abstract The Council for International Organizations of Medical Sciences (CIOMS) has played a pivotal role in shaping the global framework for pharmacovigilance, the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs). Through its expert working groups, CIOMS has developed

A Critical Intersection of Public Health and Pharmaceutical Science Abstract Pharmacoepidemiology is the study of the use and effects of drugs in large populations, combining epidemiological methods with pharmacology. It plays a pivotal role in drug safety, identifying, evaluating, and mitigating the risks associated with pharmaceutical products. With increasing drug use globally and the rise

Pharmacovigilance and the Role of SlideShare in Knowledge Dissemination Abstract Pharmacovigilance (PV) refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) or any other drug-related problems. The increasing complexity of global healthcare systems and the growing volume of medicinal products have made the monitoring of

Synergistic Approaches for Drug Safety and Efficacy AbstractClinical research and pharmacovigilance (PV) are integral components of the healthcare ecosystem, both playing crucial roles in ensuring the safety, efficacy, and quality of pharmaceutical products. While clinical research primarily focuses on evaluating the safety and efficacy of new drugs through clinical trials, pharmacovigilance is concerned with monitoring

Current State of Affairs, Challenges, and Prospects AbstractPharmacovigilance (PV) refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse events or any other drug-related problems. In Russia, pharmacovigilance has evolved significantly since the country’s integration into the global healthcare landscape. This article reviews the current state of pharmacovigilance in

Pharmacovigilance guidelines provide the framework for ensuring drug safety by monitoring, detecting, and preventing adverse drug reactions (ADRs) and other drug-related problems. Developed by regulatory authorities and international organizations, these guidelines set standards for the collection, evaluation, and reporting of safety data throughout the drug lifecycle. Pharmacovigilance (PV) Guidelines: Ensuring Drug Safety and Compliance Pharmacovigilance