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Medication Errors Why is it Important to Record, Assess, and Prevent Them

Medication errors are an important concern in healthcare systems around the world. They can occur at any stage of the medication process, from prescribing to ...
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Why you Should Incorporate Signal Detection Process in Early Phase Clinical Development Programs

What is a Safety Signal in Pharmacovigilance? Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, ...
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Navigating the Unique Challenges of AI and Automation in Pharmacovigilance: The Vital Role of Computer System Validation (CSV)

Artificial Intelligence, Machine Learning, Automation, Cost Reduction: all the buzzwords in pharmacovigilance! Everyone seems to be implementing Automation and AI in pharmacovigilance to reduce manual ...
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Overview of Regulatory Requirement for Post-Marketing Medical Device Reporting in the USA and the EU

Meteriovigilance is the term used in the context of surveillance of medical devices and its purpose is to improve the health and safety of patients, ...
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Audits in Pharmacovigilance: A Commitment to Safety

In the realm of healthcare, ensuring patient safety is the most important aspect. That’s where pharmacovigilance plays a role in safeguarding lives by monitoring the ...
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Causality Assessment in Pharmacovigilance

An adverse drug reaction is distinguished from an adverse event by the fact that in an adverse drug reaction, a causal relationship is suspected between ...
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Pharmacovigilance for Decentralized Clinical Trials

Decentralised clinical trials make clinical trials easier for patients by reducing the need to travel to clinical sites. They are also known as “Direct-to-participant trials” ...
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Medical Literature Monitoring

The medical literature is a vital source of information for monitoring the safety and benefit-risk profile of medicinal products. It is a significant source of ...
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Responsible Person for EudraVigilance

Introduction EudraVigilance is a centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European ...
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Annual Summary Reports for Health Canada: Overview, Requirements, Format and Submission

What is an Annual Summary Report (ASR)? It is a comprehensive assessment of all known safety information for a marketed drug or natural health product. ...
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Are ALT & AST Elevations Really Liver Function Tests

Liver biochemical tests are very commonly performed in clinical studies/clinical practice. These tests include: Alanine/aspartate aminotransferases (ALT/AST), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) Bilirubin, Albumin ...
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Serious Adverse Event Reconciliation in Clinical Studies

Serious Adverse Event Reconciliation in Clinical Studies WHAT IS SERIOUS ADVERSE EVENT (SAE) RECONCILIATION AND WHY IS IT REQUIRED​ The aim of Good Clinical Practice ...
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Liver Injury with Cancer Chemotherapy

Liver Injury With Cancer Chemotherapy Cytotoxic chemotherapy is frequently associated with serum aminotransferaseelevations that are self-limited and that may subside with continued therapy.However, rare occurrences ...
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Drug Induced Liver Injury in Premarketing Clinical Trials

Drug Induced Liver Injury in Premarketing Clinical Trials DILI (Drug Induced Liver Injury) is a rare but potentially fatal adverse drug reaction. DILI is a ...
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