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.
What is Quality Risk Management (QRM)?
Quality Risk Management (QRM) is a systematic process used to identify, assess, control, communicate, and review risks that may impact the quality of products or services. It is widely applied in industries such as pharmaceuticals, biotechnology, medical devices, and manufacturing to ensure consistent quality, regulatory compliance, and patient or customer safety.
What Is an INAD (Investigational New Animal Drug)?
Investigational New Animal Drug (INAD) is an important aspect in the pharmaceutical and veterinary regulatory environment that facilitates the transfer of innovative animal health products out of the laboratory into the market. An INAD is a regulatory filing by the U.S. Food and Drug Administration (FDA) (via the Center of Veterinary Medicine (CVM)) by which a company or sponsor is permitted to legally transport and test an unapproved new animal drug across state boundaries in order to conduct research.