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Evolution of EU drug safety reporting tools

Evolving Safety Reporting in the EU: Beyond EudraVigilance to EVDAS & SPOR 

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With safety reporting in the European Union (EU) entering a new era of digital integration and oversight, pharmacovigilance systems have become more connected, data-driven, and strategically central to regulatory compliance. What once revolved around manual case handling and isolated national databases has transformed into a highly interconnected pharmacovigilance network. This shift is not only redefining […]

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Types of vigilance in life science industry

Types of Vigilance Every Life Sciences Professional Should Know 

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In the global life sciences industry, whether you’re launching a new pharmaceutical, a medical device, or a personal care product, the responsibility doesn’t end at regulatory approval. It extends across the product lifecycle, driven by a commitment to patient and consumer safety, and reinforced by an evolving web of global regulatory requirements.    Traditionally associated

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Automating Medical and Scientific Literature Monitoring for Drug Safety

Automation of Literature Monitoring for Pharmacovigilance

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Literature monitoring, a key component of pharmacovigilance (PV), involves searching and analyzing medical and scientific publications, including journal articles, case reports, conference abstracts, and online content to identify reports of ADRs, safety signals, or other pertinent information. This surveillance is essential for detecting previously unknown adverse reactions or risks that may not have emerged during

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Role of Pharmacovigilance Audits in Drug safety

Pharmacovigilance Audits: Ensuring Drug Safety

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Edit with Elementor Loading Behind every safe and effective medicine on the market lies a complex system of checks and balances and key parameter of that system are pharmacovigilance (PV) audits. While they might not grab headlines like clinical trials or breakthrough approvals, PV audits are the quiet guardians of drug safety, ensuring that pharmaceutical

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REMS Audits and Inspections

REMS Audits and Inspections: What You Need to Know

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Risk Evaluation and Mitigation Strategies (REMS) are special safety programs required by the U.S. Food and Drug Administration (FDA) for certain drugs and biologics with serious safety concerns. These programs are designed to ensure that a product’s benefits outweigh its risks. REMS may include strategies such as restricted distribution, prescriber certification, patient education, training, and

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Key Developments & Implications of the European Health Data Space

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In an age where data is often called the new oil, the healthcare sector is sitting on a goldmine of untapped potential. Every day, vast amounts of health data are generated across the European Union, offering incredible opportunities to transform the way healthcare is delivered, researched, and managed. Enter the European Health Data Space (EHDS)—a

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Challenges Risk Assessment in Veterinary

Navigating the Complexities of Risk Assessment in Veterinary Pharmaceuticals 

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The development of veterinary medicines faces numerous challenges that are unique compared to human pharmaceutical development. Although the pharmaceutical industry in both sectors is built on shared principles of safety and efficacy, the veterinary pharmaceutical industry is confronted with a significantly more complex risk environment. The distinctive risk assessment challenges of veterinary pharmaceuticals and how

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Roadblocks in Global Pharmacovigilance Harmonization

Overcoming Roadblocks in Global Pharmacovigilance Harmonization

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Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Global Pharmacovigilance Harmonization, on the other hand, refers to the process of aligning regulations, practices, and standards across countries and regions in order to

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pharmacovigilance approach for biosimilars market

Pharmacovigilance Approaches for Biosimilars Market Success 

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The pharmaceutical field has witnessed a tremendous growth of innovation and success in the past few years. Among these advancements, biosimilars have become essential for improving patient access and reducing the cost of therapies. The complexities that even a slight manufacturing differences can lead to variations in protein structure, post-translational modifications, and glycosylation patterns. Since

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Current Trends patient engagement in healthcare

Patient Engagement in Healthcare: Current Trends and Future Opportunities

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For years, the focus of healthcare development and delivery has been on treatment and outcomes, often with limited input from patients. However, there is now a growing recognition that patients should not just be passive recipients of care—they should be active participants in their own healthcare journey. This patient-centered approach is transforming the way drugs

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