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Addendum to the clinical overview

The addendum to the clinical overview collects all cumulated effectiveness and safety data related to a medicinal product since MA or its last renewal, in order to obtain a new renewal for any medicinal product. It is an essential safety report to reevaluate the current benefit/risk balance, assuring patients’ health and safety.

An expert on drug safety shall be the person in charge to supervise that all information is trustworthy and to develop this report according to National Authorities’ requirements. The expert must sign and add the CV with the addendum to certify the technical and professional qualifications, training and experience to face the writing of an ACO.

The development of safety reports must combine different technical knowledge of a huge variety of safety and scientific topics; so, a key factor to accomplish success when renewing the authorization is to have a safety expert who is able to establish relationships between data from different reports and sources.

First step to develop an addendum to the clinical overview, is to review all relevant data which can affect to risk/benefit balance, including PSURs, actions taken during the last period covered by last ACO, worldwide marketing authorization status and other relevant safety information like signals.

Besides, safety experts shall evaluate clinical trials data and worldwide post-marketing exposure information to identify any relevant pattern of the use of the medicinal product, providing a brief description of that pattern.

The result of this analysis must provide a series of findings that will conduct to a discussion where the safety expert is in good position to demonstrate with evidences why the medicinal product is safe and effective, and its authorization must be renewed.

European Medicines Agency can demand an addendum to the clinical overview at any time, so it is very important to have experts who can respond to EMA in an agile and accurate way. These experts must transform clinical data into evidences to assure that the product will continue in the market.

It is essential to count with a multidisciplinary team, able to integrate different pharmacological data to fulfill all the National Authorities’ requirements, that are increasing along the time.

In Azierta we have a team of safety experts able to prepare any kind of safety report, helping companies to ensure safety and maintain a good risk-benefit ratio of their medicinal products.

Check out our ACO presentation or visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.

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