How to make better use of patient registries to collect high-quality data on medicines

Workshop to be broadcast live on 28 October

A workshop on patient registries will discuss concrete solutions to better use existing patient registries that collect high-quality data from the use of medicines in clinical practice. The workshop organised by the European Medicines Agency (EMA) on 28 October 2016 also aims to explore how new registries can be established when needed.

The workshop will be broadcast live on the EMA website on the event page. It will bring together registry owners, pharmaceutical companies, representatives from health technology assessment bodies, regulators as well as patients and healthcare professionals.

The discussions will focus on:

• identifying the challenges and opportunities for collaboration between stakeholders;
• understanding the technical challenges preventing greater use from existing registries;
• identifying concrete solutions to facilitate collaboration and better use data from existing registries.

EMA is organising this workshop as part of a broader initiative launched in September 2015 to explore ways of expanding the use of patient registries.

Registries collect information over time on patients who are diagnosed with a particular disease or who receive particular treatment(s). They can play an important role in collecting information on medicines both in the pre-authorisation and post-authorisation period. The information collected in patient registries can complement the data available on medicines from other sources to more effectively monitor the risks and benefits of authorised medicines.

Regulators sometimes require pharmaceutical companies to establish a registry to collect information on the safety and efficacy of a specific medicine in clinical practice. Although existing registries are sometimes available at national or international levels, there are often challenges in using them, in particular due to lack of access and collaborations and to differences in the type and structure of the data being collected.

To address these problems, EMA seeks to promote tools and standards to support a more systematic and standardised approach to registries.

The Agency's initiative includes two components: a strategy on registries; and a pilot phase that aims to test different components of the strategy.

Discussions at the workshop will be taken into account in the recommendations that EMA will release at the end of the pilot phase which is expected by the end of 2017. A workshop report will also be made available.

EMA's initiative on patient registries is supported by a task force comprising representatives from EMA scientific committees and working parties, representatives from the European Commission, and experts from national competent authorities.