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Welcome to the European Medicines Agency’s online media centre. This page highlights information which is of specific interest to media professionals.
The page is kept updated with news, events and information for journalists with a professional interest in the development and availability of medicines in the European Union.
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News for media professionals
Bruno Sepodes and Lesley Greene appointed for new three-year mandate ... Read more
Focus on mid-year report and interactions with key stakeholders ... Read more
All European Medicines Agency (EMA) information technology (IT) systems will be unavailable from 20:00 on Friday 30 October to 6:00 on Tuesday 3 November 2015 (UK time). ... Read more
Executive Director to be appointed following hearing at European Parliament ... Read more
Deadline to submit expressions of interest to represent civil society at PRAC and CAT to European Commission extended until 18 October. ... Read more
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Events of interest
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 workshop provided an opportunity to discuss expectations with different stakeholders such as members of the European Medicines Agency (EMA) Healthcare Professionals’ Working Party, the Patients’ and Consumers’ Working Party, the Pharmacovigilance Risk Assessment Committee, representatives of young people from the Paediatric Committee, experts in pharmacovigilance, medical ethics and data protection as well as the IMI WEB-RADR Consortium. The report on the outcome of the workshop hosted by EMA is available on the IMI website. ... Read more
12/11/2015 - 13/11/2015
Workshop on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
The objective of the workshop is to discuss the important advances made in the field of pharmacokinetics-pharmacodynamics of antibacterial agents since the entry into force of the Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99). The workshop take place during the six-months consultation period for the new draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (EMA/CHMP/594085/2015). It is expected that the discussions will contribute to shaping the final draft guideline. The workshop is one of the key activities of the European Medicines Agency (EMA) to facilitate development of new antibiotics (including those targeting the treatment of multi-resistance bacteria) and is part of EMA's contribution to the global efforts of tackling antimicrobial resistance. Registration by invitation only. ... Read more
Second stakeholder meeting on the implementation of the European Medicines Agency's policy on publication of clinical data for human medicines
On 7 September 2015 the European Medicines Agency (EMA) organised a face-to-face meeting to follow-up the meeting which took place on 6 July. The aim of this meeting was to further consult with stakeholders on the two sets of guidance under development, on the identification and redaction of commercially confidential information in the clinical reports submitted to the EMA for publication, and on the anonymisation of the clinical reports, in the context of the policy. EMA also presented new technical guidance on the procedural aspects related to the submission of the clinical reports, for example practical matters of how material should be sent to EMA, as well as the workflow of the redaction consultation process and the overall process leading to publication. ... Read more
This workshop aims to help clarify the concept and demonstration of significant benefit of new orphan medicines over existing treatments; discuss existing methodologies for comparative efficacy and effectiveness and for major contribution to patient care, including patient preferences, and how these could be applied in demonstrating significant benefit at marketing authorisation; and discuss the impact of significant benefit on health-technology-assessment (HTA) evaluation, pricing decisions and patient access. The workshop is targeted at medicine developers, regulators, healthcare professionals, academia, patients, HTA bodies and healthcare payers. Registration open until 31 October 2015. Places limited. ... Read more
Stakeholder meeting on product shortages due to manufacturing and quality problems: developing a proactive approach to prevention
In October 2013, a workshop held at the European Medicines Agency (EMA) led to the formation of an inter-industry association taskforce to propose possible solutions to the root causes of shortages due to manufacturing and quality problems. EMA is hosting a follow-up workshop on 9 October 2015 to discuss the solutions proposed by industry associations. Registration by invitation only. A live broadcast of the workshop will be available. ... Read more
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