Healthcare Professionals

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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.

Featured information

  • Antibiotic awareness initiatives, 13-19 November 2017

    EMA has published a package of information in support of World Antibiotic Awareness Week from 13 to 19 November and European Antibiotic Awareness Day on 18 November. This includes a visual guide to how the EU agencies support the fight against antibiotic resistance and a meeting report and video on its joint info session with the European Centre for Disease Prevention and Control on antimicrobial resistance in September, involving EMA's working parties for patients and consumers and for healthcare professionals. For more information, see Antimicrobial resistance.

  • Ten-year report on implementation of the Paediatric Regulation

    In October 2017, the European Commission published a report on progress made in children's medicines since the Paediatric Regulation came into force 10 years ago. The report shows an increase in medicines for children in many therapeutic areas in the last ten years, most notably in rheumatology and infectious diseases. However, it also shows that little progress has been made in diseases that only affect children or where the disease shows biological differences between adults and children, particularly rare diseases. The Commission and EMA and its Paediatric Committee will develop an action plan to improve the implementation of the Regulation.

  • public_hearing_report

    Public hearing at EMA

    Patients, carers, doctors, pharmacists and academics shared their experiences with valproate, a medicine currently prescribed for epilepsy, bipolar disorder and migraine, at EMA’s public hearing on 26 September 2017. 65 people attended including 28 patients and patient representatives, 19 healthcare professionals and academics, 11 attendees from pharmaceutical industry and 7 from media. There were 25 speaker contributions,grouped into 16 speaker slots. The European Parliament representative concluded that the hearing was a positive experience. A summary report is available.

  • Joint meeting of patients and consumers and healthcare professionals working parties

    EMA held a joint meeting of the Patients' and Consumers' Working Party (PCWP) and the Healthcare Professionals' Working Party (HCPWP) on 20 September. Topics included work plans for 2018-19, proposed revision of their mandates and rules of procedure, streamlining the eligibility status re-assessment processes, compassionate use of medicines, EMA preparedness for Brexit, EMA’s first public hearing and next steps following the European Commission report on product information. All presentations are available.

  • biosimilars

    Biosimilar medicines

    EMA and the European Commission have published an information guide for healthcare professionals on the science and regulation underpinning the use of biosimilar medicines. EU scientific experts and organisations representing doctors, nurses, pharmacists and patients contributed to the development of this guide.

News for healthcare professionals

Events of interest

  • 21/11/2017

    EMA

    Training session for patients and consumers interested in European Medicines Agency activities

    This one-day training session for representatives of patients' and consumers' and healthcare professionals’ organisations aims at presenting an overview of medicines evaluation with specific emphasis on where and how they can be involved. Using a hands-on interactive approach, participants will learn more about how they can contribute to scientific advice procedures, Scientific Advisory Group (SAG) meetings and in review of information for patients. ... Read more

  • 24/11/2017 - 25/11/2017

    EMA

    Third tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents

    This meeting built on the work of previous two meetings between the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the way these regulators approach the evaluation of antimicrobials, aiming at identifying further areas for convergence. The three agencies agreed to further align how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea or uncomplicated urinary tract infections. They also committed to working together to explore how to better streamline paediatric development of new antibacterial agents and discussed he importance of characterising the pharmacokinetic-pharmacodynamic relationship and monitoring the benefit-risk balance throughout the medicine lifecycle. The agencies plan to meet again in 2018. ... Read more

  • 18/09/2017 - 19/09/2017

    EMA

    Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations

    This two-day awareness session is for international regulators and non-governmental organisations. It gives an insight into the European Union (EU) regulatory system for medicines and the role of the European Medicines Agency (EMA). Insight into the EU system is of prime importance in an increasingly globalised world where worldwide regulators rely on close cooperation. The EU system is one of the most advanced in the world, but it is also one of the most complex. It is based on a network of decentralised agencies in the EU Member States, supported and coordinated by EMA. ... Read more

  • 30/11/2017 - 01/12/2017

    EMA

    Data anonymisation workshop

    The data anonymisation workshop focuses on anonymisation as a key enabler for clinical data sharing. The scope of the workshop includes clinical trial data including individual patient level data and real world data in the context of patient registries and individual cohort studies. ... Read more

  • 07/07/2017

    EMA

    Multiple sclerosis workshop - Registries initiative

    The EMA’s initiative for patient registries explores ways of expanding the use of patient registries in the benefit-risk evaluation of medicines within the European Economic Area. The participants of the workshop on Multiple sclerosis registries included representatives from the European MS Platform (EMSP) and its EUReMS group, the “Big MS Data” group, national MS registries, marketing authorisation holders, health technology assessment and reimbursement bodies, patients, national competent authorities, and the EMA. The workshop objectives were to agree on implementable recommendations on the core data elements to be collected in registries, protocols, consents, governance and registry interoperability and on the actions needed from the stakeholder groups to advance registry use in supporting regulatory benefit-risk evaluations. ... Read more

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