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Postmarketing Adverse Drug Experience (PADE) Inspections – Part I
Legal Framework of PADE Inspections PADE Statutory Provisions / Regulations: Prescription Drug Products for…
Audits in Pharmacovigilance: A commitment to Safety
In the realm of healthcare, ensuring patient safety is the most important aspect. That’s where…
Causality Assessment in Pharmacovigilance
The causality assessment of adverse events, to determine the relationship or connection between the drug…
Blogs
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10 Min Read
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…
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10 Min Read
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…
Soterius
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10 Min Read
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…
Soterius
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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10 Min Read
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…
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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…
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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…
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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…
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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…
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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 administration, and can have serious…
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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, or a new aspect of…
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10 Min Read
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…
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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 work and reduce costs of…