What is Quality by Design (QbD) in Regulatory Affairs?
Quality by Design (QbD) in Regulatory Affairs is a systematic, science-based approach to pharmaceutical development that focuses on building quality into a product from the earliest stages rather than testing it at the end.
What is a Pre-IND Meeting for US FDA?
A Pre-IND meeting for the US FDA is a formal meeting between a drug sponsor and the U.S. Food and Drug Administration (FDA) that takes place before submitting an Investigational New Drug (IND) application. The purpose of this meeting is to obtain regulatory guidance on the planned preclinical studies, clinical trial design, manufacturing information, and overall development strategy.
What is a Periodic Benefit-Risk Evaluation Report (PBRER)?
A Periodic Benefit-Risk Evaluation Report (PBRER) is a comprehensive pharmacovigilance document submitted by Marketing Authorization Holders (MAHs) to regulatory authorities to evaluate a medicine’s ongoing safety profile and its overall benefit-risk balance. The PBRER provides a structured analysis of new safety data collected during a defined reporting interval and determines whether the product’s benefits continue to outweigh its risks.
What is a Public Assessment Report (PAR)?
A Public Assessment Report (PAR) is an official regulatory document that provides a scientific summary of the evaluation of a medicinal product after it has been approved. It explains how a regulatory authority assessed the quality, safety, and efficacy of a product before granting marketing authorization. The PAR promotes transparency by making key assessment details publicly accessible.
What is Quality Control (QC) in Pharma?
Quality Control (QC) in Pharma refers to the set of procedures, testing methods, and documentation practices used to ensure that pharmaceutical products meet predefined quality standards before they are released to the market. QC is a critical component of pharmaceutical manufacturing that focuses on verifying product safety, purity, potency, and consistency.