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.
Human medicines highlights for 2016
EMA has released an overview of its key recommendations in 2016 on the authorisation of new medicines. EMA recommended 81 medicines for marketing authorisation. This includes recommendations for 27 new active substances.
Revised framework for interaction
The revised framework describes the objectives of the Agency’s interaction with healthcare professionals. It aims to promote participation in EMA’s work and ensure a sustainable model of interaction with healthcare professionals. The revised framework incorporates experience gained and aligns with the EU Network strategy to 2020. It complements the objectives of the frameworks of interaction with patients and consumers, and industry stakeholders.
Adaptive pathways workshop
In collaboration with the European Commission, EMA held a workshop on adaptive pathways to gather the views and proposals from stakeholders on the adaptive pathways approach, following the publication of the final report on the pilot project. 18 representatives of patient, consumer and healthcare professional organisations participated in the workshop, which included a session on patients’ needs. A summary report of the meeting is available.
Big data workshop
Rapid developments in technology have led to the generation of vast volumes of data, which can potentially transform the way the benefit-risk of medicinal products is assessed. EMA held a workshop in November 2016 to gather information on the latest developments in big data from the perspective of all stakeholders. This helps EMA and the European medicines regulatory network to identity how and when the multitude of data sources may contribute to medicine development, authorisation and post-marketing surveillance.
News for healthcare professionals
Comments from stakeholders invited until 18 May 2017 ... Read more
Mandate to cover three years ... Read more
Doctors prescribing Uptravi are advised to adhere to current prescribing information ... Read more
EU PAS Register increases transparency of research in medicines after they have been authorised in the EU ... Read more
PRAC starts a safety referral and concludes one ... Read more
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Events of interest
The ninth annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) aims to bring relevant stakeholders together to discuss requirements, barriers and opportunities for high-quality clinical studies in children. Among the highlights of this year’s workshop are the recent efforts to increase cooperation between the European Union and the United States to facilitate global paediatric trials and medicine developments. ... Read more
29/03/2017 - 30/03/2017
Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop
Three projects, Asterix, IDeAl and InSPiRe, are funded by the EU within the Seventh Framework Programme (FP7)to develop new methodology on design and analysis of small population clinical trials since 2013. The projects are in their final phase, and are ready to discuss their results to date. The aim of the workshop is to translate and promote results and novel methodologies into tangible recommendations to advance the clinical research and development of medicines and new treatments for patients with a rare disease and personalized medicine. The results to date and draft recommendations for application will be discussed by international representatives of patient organisations, pharmaceutical industry, academic statisticians and clinical trial methodologists, clinical researchers, pharmaceutical industry and regulators. ... Read more
30/01/2017 - 31/01/2017
Multi-stakeholder paediatric oncology strategy workshop (cancers with anaplastic lymphoma kinase aberrations)
The aim of the European Medicines Agency / ACCELERATE platform's workshop is to review unmet therapeutic needs of children with certain types of cancer and opportunities for targeted paediatric development of innovative anti-cancer medicines. The workshop brings together stakeholders from patient organisations, academia, pharmaceutical industry and regulators. The types of cancers that discussed during the workshop include soft tissue and lymphoid and embryonal neoplasms such as inflammatory myofibroblastic tumour, rhabdomyosarcoma, anaplastic large cell lymphoma and neuroblastoma. Important biological aberrations such as of the anaplastic lymphoma kinase (ALK) occur across these diverse cancers, albeit in small numbers of patients, and represent challenges to address the therapeutic needs of affect paediatric patients. ... Read more
14/11/2016 - 15/11/2016
Workshop on identifying opportunities for ‘big data’ in medicines development and regulatory science
Rapid developments in technology have led to 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 Medicines Agency and the European Union medicines regulatory network to gather information on the latest developments in big data from the perspective of all stakeholders in order to identity how and when the multitude of data sources may contribute to medicinal product development, authorisation and post-marketing surveillance. ... Read more
European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
This joint PCWP/HCPWP meeting includes the election of the PCWP and HCPWP co-chairs for the 2016 – 2019 mandate. Personalised medicines are discussed and participants are updated on the PCWP/HCPWP topic groups; the 2017 work programme; the framework of collaboration with academia; and feedback is given from the scientific committees. ... Read more
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