The EMA Patient Registry Initiative and the Cross-Committee Task Force on Registries have explored ways to improve the use of patient registries in the context of benefit-risk evaluation of medicinal products.
The guideline was developed based on the comments received on the discussion paper on ‘Methodological and operational considerations on the use of patient disease registries for regulatory purposes’, that went through a public consultation between November 2018 and June 2019, and a consultation of EMA Committees and Working parties. It focuses on studies using disease registries as a data source, and primarily targets marketing authorisation applicants and holders. It is also relevant to patients and to persons involved in the funding, creation and management of registries, those participating in the collection and analysis of registry data, and those planning to use the registry information and infrastructure to perform registry-based studies with a possible regulatory purpose. An annex provides considerations on good practice for registries to increase their usefulness for regulatory purpose.
The draft is under public consultation and CeSER Ruhr participates in the discussion at an EMA Workshop on the 19th of October 2020.
More information here
What is EuRRECa?
EuRRECa stands for European Registries for Rare Conditions. It is a project which is helping patients, health care professionals and researchers to participate in registries for rare conditions that are covered within expert networks such as Endo‐ERN – the European Reference Network (ERN) on Rare Endocrine Conditions or ERN-BOND, the European Reference Network on Rare Bone Diseases. To find out more about these networks please visit endoern.eu or ernbond.eu.
What is a Registry?
A registry is similar to a medical database containing a range of medical records. Registries are used very often these days by doctors and scientists to perform research into rare conditions. By pooling knowledge and experiences, registries can improve our understanding of these conditions and improve the care of all those affected.
What is the purpose of the EuRRECa Core Registry?
The information that will be collected by the Registry is routinely collected by your doctor as part of clinical care and this includes details of your medical history, clinical examination and treatment. The purpose of the Registry is to share this information with approved users who want to perform research using these data. These approved users may be doctors and scientists, public health or government organisations, other registries of rare conditions, the pharmaceutical industry as well as patient organisations. You can ask your hospital doctor to show you more details of the information that is stored and you can also find out more at eurreca.net.
EuRRECa Newsletter July 2020 herunterladen
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