Information for you
On this page, you will find information on the Agency’s activities that are most relevant to patients and carers, including news, and events.
You can contribute to the Agency’s work by responding to public consultations.
Learn more about how Patients and carers are actively involved in the work of the Agency.
10 year anniversary of PCWP
2016 marks the 10th anniversary of EMA's Patients' and Consumers' Working Party (PCWP). The PCWP is a unique platform for exchange and dialogue with patients and consumers on all issues related to medicines. To mark the occasion, EMA held an anniversary meeting, of which a video recording is available on the meeting page.
Annual report on EMA patient and healthcare professional interactions
EMA has published its 2015 annual report on its interactions with patients, consumers, healthcare professionals and their organisations. The report demonstrates the Agency’s continued commitment to incorporating these stakeholders' views into the regulatory aspect of medicines development.
Research on patient preferences
EMA, Myeloma UK and the University Medical Centre Groningen have completed the first stage of a survey with myeloma patients with the aim of understanding their perspectives on the benefits and risks of treatments and evaluating how to capture individual preferences for consideration in regulatory decision making. The research project follows a pilot study EMA conducted in 2015. Findings will be pulished later in 2016.
EMA and FDA collaboration on patient engagement
EMA and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on patient engagement. This will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorisation activities related to medicines.
News for patients and carers
EMA workshop to discuss treatments based on genetically modified T-cells ... Read more
European Commission publishes three-year report on implementation of pharmacovigilance legislation ... Read more
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Events of interest
15/11/2016 - 16/11/2016
Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products
The CAT is organising a two day workshop to discuss the scientific developments and regulatory requirements for products manufacture and testing, non-clinical studies and clinical development of genetically modified cell-based cancer immunotherapy products. These novel cancer immunotherapy treatments based on genetically modified T-cells are being developed and tested in clinical trials in a variety of cancers, but there are still scientific and regulatory changes to overcome to bring these innovative products to the market. The workshop is available for participants from regulatory authorities, academia, hospitals, industry, journalists and interested members of the public. ... Read more
Situations in which a medicine shows significant anti-cancer activity in an area where patients have no treatment option or where the conduct of standard trials with a comparative arm is difficult, such as in rare cancers or selected populations for example, will be considered. Workshop participants will discuss experience gained so far with marketing authorisations based on single-arm trials data, the strengths and weaknesses of different approaches, and opportunities from data sharing initiatives. They will also explore the views of various stakeholders groups and discuss the need for further regulatory guidance with the ultimate aim of optimising the development of new cancer treatments in these situations. ... Read more
Innovative Medicines Initiative WEB-RADR workshop: mobile technologies and social media as new tools in pharmacovigilance
The Innovative Medicines Initiative (IMI) WEB-RADR project aims to explore the use of mobile technologies and social media to further improve the collection and analysis of information on the suspected adverse drug reactions. This includes the use of mobile apps to report adverse reactions, the possibility identifying potential safety issues with medicines from user comments (posts) on social media as well as the safety information on medicines. The second workshop provides an opportunity to engage with consumers, patients, healthcare professionals and medicines regulatory authorities to discuss latest developments and to obtain input and feedback to maximise the utility and benefits of the project deliverables. ... Read more
14/11/2016 - 15/11/2016
Rapid developments in technology have resulted in the generation of vast volumes of data, which have the capability to transform the way the benefit-risk of medicinal products is assessed over their entire life cycle. However, it is recognised there are multiple challenges in the exploitation of these data. These range from the fundamental need to establish methods to enable the access to, integration and analysis of heterogeneous datasets to understanding the limitations in its use. Importantly, robust and transparent mechanisms to protect patient confidentiality are key to secure patient trust. It is important for the European Union medicines regulatory network to gather information on the latest developments in big data from the perspective of all stakeholders and to understand how the multitude of data sources may contribute to medicinal product development, authorisation and post-marketing surveillance in order to be in a position to anticipate and prepare for such changes. ... Read more
Through the Patient Registry Initiative launched in September 2015, the EMA aims to facilitate interactions between registry co-ordinators and potential users of registry data both at an early stage of the development, during the marketing authorisation evaluation procedure and post-authorisation. This workshop is designed to bring together multiple stakeholders including registry owners, industry, HTA representatives and regulators to discuss the challenges and barriers to collaboration and identify specific solutions. More specifically the workshop aims to: - Identify the challenges faced by registries and industry when collaborating; - Understand the technical challenges presented by disparate datasets; - Identify concrete solutions to better facilitate relations to avoid duplication. ... Read more
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