Category: Pharmacovigilance

Pharmaceutical industries require their products to be able to promote drug safety during the lifecycle of such products. The Pharmacovigilance System Master File (PSMF) is one of the most important documents in favor of this endeavor in the European Union (EU) and other areas. So, what is a PSMF and why is this so essential… Continue reading What is a Pharmacovigilance System Master File (PSMF)?

ICSR Management: Ensuring Patient Safety Through Effective Case Handling In pharmacovigilance, adverse drug reaction (ADR) report gathering and analysis is critical to the overall protection of the health of the population. Another essential part of this initiative is the Individual Case Safety Report (ICSR) a harmonic framework of storing and reporting the suspected adverse reactions… Continue reading ICSR Management: Ensuring Patient Safety Through Effective Case Handling

Pharmacovigilance Risk Management: Protecting Patient Safety Through Proactive Strategies Pharmacovigilance is a crucial science, which secures the unnecessary safety of drugs, once they enter the market. At the core of this is risk management, which is a preventive exercise that aids in identifying, analyzing, and reducing the risk involved in pharmaceutical products. Proper risk management… Continue reading Pharmacovigilance Risk Management : Protecting Patient Safety Through Proactive Strategies

Signal Management in Pharmacovigilance: Detecting and Acting on Safety Concerns Signal management in pharmacovigilance is a key process that facilitates safety of the patient by detecting, assessing, and controlling possible safety concerns of medicinal products. Signals are have information implying a new or modified bad event that potentially must be studied or regulated.

GVP Module VI Addendum II: Masking Personal Data in ICSRs – A Vital Step Toward Privacy Pharmacovigilance plays a crucial role in safeguarding public health. However, as data flows through systems like EudraVigilance, protecting personal data becomes equally essential.

Effective Preparation for Pharmacovigilance Inspections: Key Steps for MAHs Pharmacovigilance (PV) inspections are a crucial part of ensuring public health safety within the European Union (EU). These inspections are conducted by national competent authorities in cooperation with the European Medicines Agency (EMA) to verify that marketing authorisation holders (MAHs) are meeting their pharmacovigilance obligations.

AI-Powered Pharmacovigilance: The Future of Drug Safety Surveillance Artificial Intelligence (AI) refers to the simulation of human intelligence in machines, enabling them to perform tasks such as learning, reasoning, and problem-solving. In healthcare, AI has already shown significant promise in areas like diagnosis, treatment planning, and personalized medicine, transforming patient care delivery.

Pharmacovigilance System Master File (PSMF): Its Importance and Regulatory Role in Ensuring Drug Safety The Pharmacovigilance System Master File (PSMF) is a key regulatory requirement under the EU pharmacovigilance legislation, ensuring that medicinal products authorized in the European Union (EU) comply with the stringent safety monitoring and reporting standards. Its primary objective is to provide… Continue reading Pharmacovigilance System Master File (PSMF): Its Importance and Regulatory Role in Ensuring Drug Safety

Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQ) What is ADE FUQ? The Adverse Drug Event Follow-Up Questionnaire (ADE FUQ) is designed to provide guidance to the EU/EEA regulatory medicines network on the appropriate use of Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs) in routine pharmacovigilance activities, as outlined in the Good… Continue reading Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQ)

Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance In the world of pharmaceutical regulation, ensuring the ongoing safety of medicinal products post-market approval is just as crucial as during their development. One of the most important documents used to monitor and evaluate the safety of a drug after it hits the market… Continue reading Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance