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 ...
Read More → 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, ...
Read More → 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 ...
Read More → 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, ...
Read More → 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 ...
Read More → 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 ...
Read More → 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” ...
Read More → 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 ...
Read More → 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 ...
Read More → 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. ...
Read More → 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 ...
Read More → 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
Read More → 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 ...
Read More → 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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