Information for you
On this page, you will find information on the Agency’s activities that are most relevant to healthcare professionals, including news, and events.
You can contribute to the Agency’s work by responding to public consultations.
Learn more about how Healthcare Professionals 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.
Resources for healthcare professionals
EMA updated its online content for healthcare professionals and added Resources for healthcare professionals. This page provides links to relevant content on themes including summary of product characteristics, medication errors and relevant workshops. It also includes a series of short videos called EMA Basics. These cover the role of EMA, the centralised procedure and how EMA works with healthcare professionals. 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 healthcare professionals
Joint EMA/ESMO workshop to be broadcast live on 30 June 2016 ... Read more
Six new medicines, including one cell-based therapy, recommended for approval ... Read more
Orphan medicine Zalmoxis recommended by CAT and CHMP for marketing authorisation ... Read more
EMA has started a review of medicines manufactured by Pharmaceutics International Inc., USA. ... Read more
Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia
EMA recommendation follows early termination of a clinical trial in these patients ... Read more
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Events of interest
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
2016 marks the 10th anniversary of the European Medicines Agency’s (EMA) PCWP. A working group of patients' organisations was first created in 2003. Following endorsement of its framework of interaction by EMA’s Management Board, the working group was formalised into an official working party, the PCWP. Building on the importance of multi-stakeholder dialogue, the PCWP regularly holds its annual meetings jointly with the Healthcare Professionals’ Working Party. The PCWP is a unique platform for exchange and dialogue with patients and consumers on all issues related to medicines. The EMA is proud of the work of the PCWP and this anniversary meeting will be an opportunity to reflect on past successes and to plan for the future. ... Read more
17/05/2016 - 18/05/2016
In 2013, the European Medicines Agency (EMA) published a concept paper on extrapolation of efficacy and safety in medicine development. It aims to discuss the need and possibility of developing a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. The framework will set out a structured approach for each extrapolation exercise, in order to improve interactions with stakeholders and to standardise decision making across committees. Further to the extrapolation expert meeting that took place in September 2015, EMA will publish a reflection paper on extrapolation across age groups that will include considerations specific to global product development and licensing of paediatric medicines. This workshop will present the reflection paper and seek feedback from developers. ... 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
This information day provides a forum to discuss ongoing activities and status of periodic safety update report (PSUR) single assessment procedures, with a particular emphasis on the PSUR roadmap and how it supports reaching a common understanding of the single assessment. The roadmap is key to optimising the process and content of PSURs and the EU single assessment (PSUSA). The information day will also look into the procedural improvements that are already implemented and discuss further improvements based on views from the pharmaceutical industry. The event will also provide an opportunity for industry, EMA and national competent authorities to share experiences on the mandatory use of the PSUR repository lessons learned from the transition. It will also outline the role of PSURs in inspections from inspectors’ and industry’s point of view. ... Read more
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