Category: Pharmacovigilance

What Is a PADER? Understanding the Periodic Adverse Drug Experience Report Pharmacovigilance plays a critical role in ensuring patient safety throughout a product’s lifecycle. One of the key regulatory requirements in the United States is the Periodic Adverse Drug Experience Report (PADER). This report allows regulatory authorities to continuously evaluate the safety profile of approved… Continue reading What Is a PADER?

What is Eco-Pharmacovigilance? Eco-Pharmacovigilance (EPV) is the group of science and activity that is related to identifying, measuring, comprehending, and avoiding the negative impact of pharmaceutical substances on the environment. It is concerned with the detection of risks of medicinal products as soon as they get into the ecosystems either through human actions, through manufacturing… Continue reading What is Eco-Pharmacovigilance?

What Is Drug Safety? Drug safety or pharmacovigilance is the field and practice of identifying, evaluating, interpreting, and averting the negative effects or any other issues regarding drugs. Its main aim is to guarantee that drugs are safe in the lifecycle of their patient use that is, both in clinical development and in post-marketing use.

What is Risk Management in Pharma? Risk management in the pharmaceutical industry is a structured approach to identifying, assessing, and mitigating potential risks that may affect patient safety, product quality, or regulatory compliance.

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)?