Blogs

Is it Drug Induced Liver Injury (DILI), or something else?

Ever faced a hepatic signal in a trial that looked like classic drug-induced liver injury (DILI), but turned out to be something entirely different? Here’s a hypothetical scenario that might…

Medication Errors & Patient Safety – Part I

Why Medication Errors Matter More Than We Think Medication errors are a significant public health concern, often occurring during various stages of care, whether preventive, diagnostic, therapeutic, or rehabilitative. These…

Postmarketing Adverse Drug Experience (PADE) Inspections – Part IV

Legal Framework of PADE Inspections Good Corrective Action Plan - Four Reasons to Submit a Complete and Timely Written Response May be considered in an FDA compliance decision. Demonstrates your…

Post marketing Adverse Drug Experience (PADE) Inspections – Part III

Legal Framework of PADE Inspections Scientific Literature Reports Determine: If the firm reviews scientific literature and the frequency of the review. If the applicant or non-applicant is submitting expedited ICSRs…

Postmarketing Adverse Drug Experience (PADE) Inspections – Part II

Legal Framework of PADE Inspections LAW: Federal Food, Drug and Cosmetic Act (FDCA) Title 21 of the Code of Federal Regulations (CFR) FDA’s Current Thinking Inspectional Observations: USFDA 2023 1…

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Legal Framework of PADE Inspections PADE Statutory Provisions / Regulations: Prescription Drug Products for Human Use S.no FD&C Act, subchapter V, part A, section 505 (21 U.S.C. 355) Comments 1…

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 safety of medicinal products. But…

Causality Assessment in Pharmacovigilance

The causality assessment of adverse events, to determine the relationship or connection between the drug and adverse events, is an essential and complex approach in pharmacovigilance. The recognition of a…

Pharmacovigilance for Decentralized Clinical Trials

Pharmacovigilance for Decentralized Clinical Trials: Challenges and Way Forward Decentralised clinical trials make clinical trials easier for patients by reducing the need to travel to clinical sites. They are also…

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 information of suspected adverse reaction case…

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 Economic Area (EEA). EudraVigilance is…

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 (GCP) and Good Pharmacovigilance Process (GVP) is to keep patients at the…

Liver Injury With Cancer Chemotherapy

Liver Injury with Cancer Chemotherapy -Importance of the Product Label in Risk Satisfaction Cytotoxic chemotherapy is frequently associated with serum Aminotransferase elevations that are self-limited and that may subside with…

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 Prothrombin time (PT), International normalized…

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. The ASR is prepared by…

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 very common cause of acute liver failure in North America and Europe, a…

Hy’s law & Drug Induced Liver Injury – Part II

Drug-Induced Liver Injury Occurrence Most frequent cause of acute liver failure in North America and Europe. No definite causative agent has been attributed in several cases. Underlying mechanisms are still unclear and…

Hy’s law & Drug Induced Liver Injury – Part I

Drug-Induced Liver Injury Occurrence Most frequent cause of acute liver failure in North America and Europe. No definite causative agent has been attributed in several cases. Underlying mechanisms are still unclear and…

Automation Solution – UNITYdx™

Essential Automation Solution Components Technology Digital Monitoring of Safety Communications with site Tracking of Delivery Receipts and Acknowledgement Compliance Custom Configurations for Site Reminders and Email templates Complete Logical Separation…

Transforming Clinical Trial Safety: Regulatory Expectations & Inspection Findings for Site Notifications for SUSARs

US-FDA (United States Food and Drug Administration) The sponsor must notify all participating investigators (i.e., all investigators to whom the sponsor is providing drug under its INDs or under any…

Risk Evaluation and Mitigation Strategy (REMS) Compliance & Inspection

REMS are Enforceable under Section 505-1 REMS must be fully operational before drug introduced into interstate commerce. Drug is deemed to be misbranded (Section 502(y)) – If the applicant holder…

Navigating Risk Evaluation and Mitigation Strategy (REMS) Audits Inspections

What is REMS? Per the USFDA, REMS is defined as: - A required risk management plan that uses risk minimization strategies beyond professional labelling to ensure that the benefits of…

Signal Detection in Early Phase Clinical Drug Trials

Why Should You Perform Signal Detection in Early Phase Clinical Drug Trials? The term ‘pharmacovigilance’ has conventionally been related with post-marketing activities; however, it is also equally applicable to the…

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 administration, and can have serious…

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, or a new aspect of…

Overview of Regulatory Requirement for Post-Marketing Medical Device Reporting in the USA and the EU

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…

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 work and reduce costs of…