What is a Development Safety Update report (DSUR)?

DSUR is a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed. A DSUR provides information to assure regulators that sponsors are adequately monitoring and evaluating the evolving safety profile of the investigational drug.

What is a Risk Management Plan?

The aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise the important risks of a medicinal product.

What is a Signal?

As per CIOMS VIII (2010), Signal is defined as the “Information that arises from one or multiple sources which suggests a potentially new causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verification action”.

What is a Periodic Benefit-Risk Evaluation Report (PBRER)?

PBRER is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions. The main objective of a PBRER is to present a comprehensive, concise, and critical analysis of new or emerging information on the risks of the medicinal product, and on its benefit in approved indications, to enable an appraisal of the product’s overall benefit-risk profile.

What is a Periodic Safety Update Report (PSUR)?

PSUR is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product and should be prepared at defined time points after its authorisation.

What are Good Pharmacovigilance Practices (GVP) and GVP modules?

GVP are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.
Guideline on GVP is divided into various chapters that are covered under modules that cover major pharmacovigilance processes and product-or population-specific considerations.

What is REMS?

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Medical Dictionary for Regulatory Activities (MedDRA)

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans.

What is an ICSR?

Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.

What is a product quality complaint?

Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorisation. It is important to report these defects in a timely manner because sometimes it is necessary to implement urgent measures to protect public health and animal health, such as the recall of one or more defective batch(es) of a medicine from the market or prohibition of supply.