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Safety Reports

Azierta is an European Consultancy with a long tradition and experience of writing top-quality Safety reports (PSUR/PBRER, ACO, RMP, DSURS, Signal Detection reports).

We are committed to patient safety helping our clients to meet the increasingly complex regulatory environment in pharmacovigilance.

What reports can you find?

PSUR / PBRER

The PBRER is a periodic assessment of the risk-benefit ratio of the medicinal product. The PBRER shall be submitted to the Health Authorities from marketing authorization, irrespective of the date of marketing. 

A periodic benefit risk evaluation report (PBRER) is necessary for all approved medicinal products (unless they are covered by the derogation given in Directive 2001/83, Article 107b.)

ACO

Addendum to the Clinical Overview (ACO) is an updated report of the module 2.5 of the registration dossier.

Is mandatory to submit and ACO in quinquennial renewals for medicinal products, and it is a critical discussion focused on the assessment of the current risk-benefit ratio of a medicinal product in order to guarantee that safety and efficacy are still positive.

RMP

The objective of a Risk Management Plan (RMP) is to determine the safety risk of medicinal products throughout post-authorization phase, and to define Risk Minimization activities  and to assess their effectiveness . The development of RMP involves to identify risks related to the use of medicinal products, taking into account potential risk and unknown safety information.

The submission is mandatory in registration dossier (module 1.8)

DSUR

DSUR is an annual safety report for Clinical Trials. This report evaluates the safety profile of the medicinal products in Clinical Trials, and the risk associated to the patients included in the study. DSUR must determine implemented or proposed actions to minimized identified risks.

This report is submitted annually to Health Authorities and ethics committees.

Signal Detection

Signal detection is defined as 'The act of looking for and/or identifying signals using event data from any source.'

To present it in a more simplified way, signal detection or signaling represents the detection of early warning signs throughout the lifecycle of medicinal products.

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