Medical Review

Review of case or signal by qualified scientific personnel (e.g., physician, pharmacist).

A predefined adverse event that requires enhanced monitoring and specific evaluation due to its potential association with the product or therapeutic class.

The ongoing evaluation comparing a medicine's therapeutic benefits against its risks to determine if the overall profile remains favorable for patients.

The reference document maintained by the MAH containing all relevant safety information about a product, serving as the basis for national labels and expectedness determination.

A critical analysis of clinical safety and efficacy data that integrates information from multiple sources into a coherent summary for regulatory submissions.

An independent group of experts that monitors patient safety and treatment efficacy data during a clinical trial and can recommend trial modifications or termination.

A cross-functional committee responsible for reviewing safety data, making risk management decisions, and overseeing the company's pharmacovigilance activities.

A study examining how a medicine is marketed, prescribed, and used in practice, providing context for safety data interpretation.

A document containing clinical and nonclinical information about an investigational product that is relevant to the study of the product in humans.

The required reporting of safety information to Institutional Review Boards or Ethics Committees overseeing clinical trials.

The official prescribing information, package insert, or Summary of Product Characteristics (SmPC) that describes a medicine's approved uses, warnings, and adverse reactions.

The clinical assessment of adverse event cases by a qualified medical professional to evaluate seriousness, causality, expectedness, and medical significance.

An adverse event case where the diagnosis or clinical details have been verified by a healthcare professional, enhancing the reliability of the reported information.

A medically qualified professional who provides clinical expertise in evaluating adverse events, assessing causality, and making safety determinations.

The EU regulatory requirement for MAHs to have a designated qualified individual responsible for the establishment and maintenance of the pharmacovigilance system.

The document used to determine expectedness of adverse reactions for regulatory reporting purposes, typically the company core safety information (CCSI) for marketed products or Investigator's Brochure for clinical trials.

Information arising from one or multiple sources that suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event.

An interim safety report during clinical trials providing cumulative safety data and analysis at specified intervals or when requested.

A regulatory submission to update product labeling or other safety documents based on new safety information, typically requiring expedited review.

The EU official document describing a medicinal product's properties and approved conditions of use, serving as the basis for healthcare professional information.

A structured process to obtain specific additional information for certain types of adverse events to enable thorough medical assessment.