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
New working group will share information and best practices ... Read more
Gonzalo Calvo appointed for a second term ... Read more
Manufacturing processes for these products successfully inactivate or remove virus ... Read more
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)
Ten* medicines recommended for approval, including three medicines for cancer. ... Read more
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Events of interest
This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years. ... Read more
The European Medicines Agency is organising this workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach, in light of the practical experience gained during the pilot project EMA ran between March 2014 and August 2016, and to plan the next steps in the exploration of this concept. Adaptive pathways is a scientific concept of medicines development and data generation intended for medicines that address patients’ unmet medical needs. ... Read more
12/09/2016 - 13/09/2016
This workshop is co-sponsored by the EMA and the Critical Path Institute. It focuses on reviewing the progress and exploring new initiatives for the International Neonatal Consortium (INC), which is dedicated to accelerating the development of safe and effective therapies for neonates. One cross-cutting topic is how to enhance a research culture. Other overarching topics are precision medicine for neonates and long-term outcome measures. Therapeutic areas that will be examined include Neonatal Abstinence Syndrome (NAS) and Necrotizing Enterocolitis (NEC). ... Read more
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
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