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.
Patients’ and healthcare professionals’ meeting
The joint meeting of patients’ and healthcare professionals’ working parties took place in March. Participants discussed interaction with patients in 2015, measuring the impact of pharmacovigilance activities, the ICH guideline on good clinical practice and access to EudraVigilance data. EMA will publish the meeting minutes and presentations.
Communication and information on medicines
Patients and healthcare professionals took part in a session on communication and information on medicines, focusing on how information on medicines is produced and used. Participants considered survey results to identify the current landscape, then discussed opportunities for improvement and future research areas. EMA expects to publish a report on the session.
Training and resources
EMA updated its online content for patients and consumers, adding information on Training and resources including EMA and external training opportunities, links to relevant workshops and materials and a series of short videos called EMA Basics. These cover the role of EMA, the centralised procedure and how EMA works with patients. More videos will follow in 2016.
Antimicrobial resistance is a growing problem in humans and in animals. EMA is concerned about the development of antimicrobial resistance, particularly resistance to antibiotics. Read more about EMA’s activities in relation to antimicrobial resistance.
News for patients and carers
EMA starts EU-wide reflection on necessary changes to best practices ... Read more
PRAC concludes on meta-analysis on the risk of inhibitor development in severe haemophilia patients receiving recombinant factor VIII products ... Read more
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Events of interest
Single-arm trials (SATs) have led to regulatory approval of oncology products in case of dramatic activity in well-defined populations with high unmet medical need. Further, when randomized-controlled trials are not possible, SATs augmented with statistical approaches may become the standard basis of evidence of efficacy for new applications. However, what constitutes dramatic activity and high unmet medical need is often debated and there is no regulatory guidance on cancer drug development in these situations and how to manage the remaining uncertainties optimally. This workshop will debate the experience gained with these types of approvals, the strengths and weaknesses of different approaches, explore the views of different stakeholders and underlying principles, and will discuss the need and appropriateness for further regulatory guidance. ... Read more
01/06/2016 - 02/06/2016
IMI ADAPT SMART, IMI GetReal and MIT NEW Drug Development ParadIGmS (NEWDIGS) “Adaptive Design Laboratory” workshop
The format of this two-day workshop is based on the NEWDIGS ‘scenario design’ methodology which leverages case studies to facilitate open yet structured discussion among stakeholders from different sectors regarding scientific, regulatory and utilization issues; and how potential options for integrated evidence generation and use plans across the product life span might help resolve those issues. In this workshop, Day 1 will focus on a retrospective case and, in particular, explore options for how Real World Evidence might be used to bridge the efficacy to effectiveness gap. Day 2 will be a retrospective review of a product, exploring “what if” Adaptive Pathways had been available, what other scenarios might have emerged in terms of its development, licensing, and utilization. ... Read more
02/06/2016 - 03/06/2016
2016 annual workshop of the European network of paediatric research (Enpr-EMA) at the European Medicines Agency
The first day of the workshop is an open meeting to all stakeholders, including patient and parent organisations, network representatives, pharmaceutical industry staff responsible for paediatric studies and regulators. The main tocpics of the workshop this year will be the deliverables of the working groups and the implementation of the new Clinical Trial Regulation with a focus on ethics related issues. The second day is dedicated to members of Enpr-EMA and its coordinating group. ... Read more
Medication errors are a major public health burden and error prevention is a shared responsibility between patients, healthcare professionals, regulators and pharmaceutical industry at all levels of healthcare delivery. This information day is an opportunity for pharmaceutical industry and regulatory agencies to exchange experience on the new European Union (EU) good practice guide on medication errors published by the EU regulatory network in 2015. The objective is to raise awareness of EU pharmacovigilance obligations for medication errors and to discuss operational aspects and good practice recommendations with regard to medication error reporting, evaluation and prevention, with insight into the current regulatory thinking on how to tackle medication errors within health care delivery systems for the benefit of patient safety. ... Read more
05/12/2016 - 06/12/2016
In January 2016 the Pharmacovigilance Risk Assessment Committee (PRAC) adopted a strategy for measuring the impact of pharmacovigilance activities performed at European Union (EU) and Member States level which relies on a collaborative approach of all stakeholders. Measuring the impact of key pharmacovigilance activities will allow regulators and stakeholders to determine which activities are most successful and to identify enablers and barriers for generating positive health impacts which will contribute to the further development of proactive pharmacovigilance systems and to promote best practice across the EU. The aim of this workshop is to facilitate the implementation of the PRAC strategy with a particular focus on the development of methodologies and the fostering of collaboration. ... Read more
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