Knowledge Base
Explore foundational concepts, inspection readiness guides, and regulatory frameworks.
Popular:
PSMF Management |
Inspections
Recent Articles
Omalizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance
Omalizumab is a humanised IgG1 monoclonal antibody that binds free immunoglobulin E and prevents its interaction with high-affinity IgE receptors. By lowering free IgE, it also down-regulates Fc epsilon RI expression on basophils, mast cells and other cells. This article explains the IgE system, omalizumab development and indication-specific use, then connects its mechanism to anaphylaxis risk, allergic-disease confounding, serum-sickness-like reactions, eosinophilic conditions, self-administration, dosing errors, biosimilar traceability and pharmacovigilance practice.
Evaluating the Fluoroquinolone–Aortic Aneurysm and Dissection Signal: From Detection to Regulatory Action
A process-focused case study showing how a safety signal can progress from uncertain epidemiological evidence to product-information action and then be refined when better-controlled studies challenge the apparent magnitude or causal interpretation.
How to Read an EMA Referral From a Pharmacovigilance Perspective
Explains how to reconstruct an EMA referral chronologically and distinguish the initiating concern, evidence assessment, PRAC recommendation, CHMP or CMDh step, European Commission decision and final implementation.
Emerging Safety Issue Assessment: Evidence, Urgency and Regulatory Decision-Making
Explains how an MAH should reason from a new safety concern to an emerging-safety-issue decision, distinguishing ESI assessment from ordinary signal management and separating GVP guidance from recommended operational practice.
EU Pharmacovigilance
83- GVP Module XVI: Pregnancy Prevention Programmes in the EU — Risk Minimisation and Member State Implementation
- GVP Module VII: PSUR Scope, Objectives and Regulatory Purpose
- GVP Module III: Pharmacovigilance Inspections
- GVP Module VI: Seriousness, Expectedness and ICSR Case Assessment
- GVP Module VIII: Imposed and Non-Imposed PASS
Product Pharmacovigilance
59- Omalizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance
- Tocilizumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance
- Pertuzumab: Classification, History, Mechanism of Action, Safety and Pharmacovigilance
- How to Write a PBRER or PSUR for a Biological Medicinal Product
- ICSR Management for Biological Medicinal Products
EU Regulatory Affairs
31- Centralised, National, Mutual Recognition and Decentralised Procedures Explained
- What Is CMDh? Role, Functions and Regulatory Significance in the EU Medicines System
- How National Marketing Authorisation Procedures Work in the EU
- How EU Marketing Authorisation Decisions Are Implemented and Maintained After Approval
- CHMP Scientific Opinions and European Commission Marketing Authorisation Decisions
Signal Management & Benefit-Risk
26- How to Read an EMA Referral From a Pharmacovigilance Perspective
- Emerging Safety Issue Assessment: Evidence, Urgency and Regulatory Decision-Making
- What Is a Safety Signal?
- Signal Validation in Pharmacovigilance
- Signal Tracking and Documentation
QPPV, Governance & PSMF
23- How to Become a QPPV
- Pharmacovigilance Governance
- What is a Local Safety Officer?
- QPPV Responsibilities
- UK QPPV Requirements
Signal Evaluation
16- Evaluating the Fluoroquinolone–Aortic Aneurysm and Dissection Signal: From Detection to Regulatory Action
- Signal Evaluation: SSRIs and Persistent Pulmonary Hypertension of the Newborn
- Historical Signal Evaluation: SGLT2 Inhibitors and Diabetic Ketoacidosis
- Historical Signal Evaluation: Fluoroquinolones and Aortic Aneurysm or Dissection
- Signal Evaluation: GLP-1 Receptor Agonists and Acute Pancreatitis
Risk Management Plans
14- Types of Risk Management Plans
- Safety Specification
- RMP Lifecycle Management
- RMP Governance and Version Control
- Risk Minimisation Effectiveness Evaluation
Drug Safety
13- Drug-Induced QT Prolongation: Cardiac Safety Assessment in Clinical Development and Pharmacovigilance
- Drug-Induced Pulmonary Toxicity: Respiratory Safety Assessment in Clinical Development and Pharmacovigilance
- Drug-Induced Kidney Injury: Renal Safety Assessment in Clinical Development and Pharmacovigilance
- Drug-Induced Cardiac Toxicity: Cardiovascular Safety Assessment in Clinical Development and Pharmacovigilance
- Drug-Induced Hematologic Toxicity: Hematologic Safety Assessment in Clinical Development and Pharmacovigilance
PBRER
12- How to Write a PBRER
- Understanding the Structure of a PBRER
- Writing the Executive Summary in a PBRER
- Writing the Worldwide Marketing Authorisation Status Section in a PBRER
- Writing the Signal Evaluation Section in a PBRER
Pharmacovigilance Inspections
10- What Is a QPPV Inspection?
- What Is a Pharmacovigilance Inspection?
- Pharmacovigilance Inspections
- Inspection Readiness in Pharmacovigilance
- Inspection Interviews in Pharmacovigilance
Audits & Quality Assurance
9- What Is CAPA in Pharmacovigilance?
- What Is a Pharmacovigilance Audit?
- QPPV and Audit Oversight
- Risk-Based Audit Planning in Pharmacovigilance
- Pharmacovigilance Audits
Vendor Management
9- Vendor KPIs and Metrics in Pharmacovigilance
- Common Vendor Oversight Inspection Findings
- Vendor Audits in Pharmacovigilance
- Vendor Qualification and Selection in Pharmacovigilance
- Vendor Risk Assessment in Pharmacovigilance
Computerised System Validation
7- User Requirements Specifications (URS) in Pharmacovigilance
- Functional Specifications and Design Specifications in Pharmacovigilance
- Validation Testing in Pharmacovigilance: IQ, OQ, PQ and User Acceptance Testing
- Traceability Matrix in Computerised System Validation
- Computerised System Validation Plan
Safety Operations
7- XEVMPD Guide for Pharmacovigilance Professionals
- What Is EudraVigilance?
- Medical Literature Monitoring in Pharmacovigilance
- EudraVigilance Registration and Access Management
- EudraVigilance Metrics and KPIs for QPPVs
EU Pharmacovigilance Inspection Findings
6- EU Pharmacovigilance Inspection Findings: Data Integrity, Traceability and the Evidence Chain
- EU Pharmacovigilance Inspection Findings: Training, Competence and Qualified Personnel
- EU Pharmacovigilance Inspection Findings: Lifecycle Management and Continuity of Pharmacovigilance Controls
- EU Pharmacovigilance Inspection Findings: CAPA Effectiveness and Recurrence of Deficiencies
- EU Pharmacovigilance Compliance Monitoring: Detecting Failures Before Inspection
XEVMPD and Article 57
4- Maintaining XEVMPD Through the Product Lifecycle: Variations, Transfers, Renewals, Suspensions and Withdrawals
- XEVMPD Data Quality: Reconciliation, Completeness and Detecting Hidden Errors
- XEVMPD Lifecycle Maintenance: Managing Variations, Transfers, Renewals and Withdrawals
- XEVMPD Data Quality: Common Errors, Validation and Maintenance