The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.

Periodic Safety Update Report

Periodic Safety Update Reports are pharmacovigilance documents submitted to the Competent Authorities, which provide an evaluation of the risk benefit balance using the worldwide safety data collected in connection to a medicinal product. Marketing Authorization Holders and Competent Authorities use this evaluation to conclude on the safety and efficacy profile of the medicinal product and decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.

Periodic Safety Update Report in the European Union/EEA

In the EU/EEA, PSURs should follow a specific format (PBRER) and submission schedule.

The frequency with which the PSURs are to be submitted shall be specified in the marketing authorization. The dates of submission according to the specified frequency shall be calculated from the date of the authorization.

The Agency (European Medicines Agency) carries out single assessments of related PSURs (PSUSA) for medicines containing the same active substances or combinations of active substances in order to harmonize and strengthen the safety and benefit-risk review of medicines across the European Economic Area. Marketing authorization holders of branded products as well as generic products are expected to submit PSURs under this single assessments process, using the EURD list as reference for submission dates and DLPs (data lock points).

Latest Glossary Definitions

Monitoring Plan

Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description of the study, its objectives, and the critical data and study procedures.

The plan describes the reference policies and procedures to follow.

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.

EUDAMED

Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

ISO14155

International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

Redaction

In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. Tthe redaction should appear as a light blue box with a black 'PPD' label or as a black box with a red 'CCI' label.

Protection of personal data (PPD)

In relation to Policy 70, “Personal data” is any information relating to an identified or identifiable natural person; an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his

Informed Consent Form (ICF)

Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.

Lay person summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These lay person summaries will be made available in the EU Portal and Database.

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