Category: Pharmacovigilance

What is Non-Clinical Regulatory Writing? In the pharmaceutical industry, precision, compliance, and scientific clarity are critical at every stage of drug development. Among the most vital, though least used roles in this process, is non-clinical regulatory writing, a medical writing type in which accurate non-clinical information is conveyed to world regulatory authorities.

What is a Risk Management Plan (RMP) ? A Risk Management Plan (RMP) is a detailed report that the pharmaceutical industry needs to make sure the benefits of a pharmaceutical product exceed its dangers. It is a required component of regulatory submission, especially in the European Union, and is a key element of the product… Continue reading What is a Risk Management Plan (RMP)

What is Orphan Drug Designation (ODD)? Orphan Drug Designation (ODD) is a regulatory designation that applies to those types of medicine which have been specifically designed to treat a rare disease commonly referred to as an orphan disease. These diseases affect a small fraction of the population, and because of the limited market potential, pharmaceutical… Continue reading What is Orphan Drug Designation (ODD)

What is Pharmacovigilance System Setup? Pharmacovigilance (PV) is an important part of the pharmaceutical sector as it plays a crucial role in ensuring safety of medicinal products in their lifecycle. Marketing Authorization Holder (MAH) and clinical research organizations (CROs) are obliged to establish a compliant pharmacovigilance system in accordance with the requirements of global regulations.

What is Pharmacovigilance Audit? Patient safety and compliance with the regulations are the most important in the pharmaceutical industry. One of the key mechanisms to ensure that drug safety processes are effective, consistent, and compliant is the pharmacovigilance audit. This internal or external assessment assists with the evaluation of the strength of the pharmacovigilance system,… Continue reading What is Pharmacovigilance Audit

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.