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.

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News for healthcare professionals

Events of interest

  • 21/09/2017

    EMA

    Eleventh stakeholder forum on the pharmacovigilance legislation

    This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years. ... Read more

  • 01/12/2017

    EMA

    European Medicines Agency (EMA) / Drug Information Association (DIA) statistics forum: The role of observational data in assessing the benefits and risks of medicines

    This forum considers the place of observational research in the clinical evaluation of medicines and seeks views on how to select promising study designs, prospectively specify objective criteria for evaluation of study results and define procedures to ensure the reliability of results. The overall aim is to contribute to the ongoing debate on how to assess research based on observational studies and in particular, how to pre-specify criteria of ‘success’ in an observational study in a way that would allow confident design of a research programme to meet regulatory requirements. These discussions will address the lack of regulatory guidance in this area, which was highlighted by moves to extend the use of epidemiological analyses (previously used primarily for prospective clinical trials) into areas of medicine development due to the increasing availability of more and higher quality observational data. ... 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

  • 03/05/2018 - 04/05/2018

    EMA

    Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

    The European Medicines Agency has published a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA/CHMP/138502/2017), for a 1-year public consultation until 31 March 2018. In order to facilitate multidisciplinary interaction between regulators and stakeholders on statistical methodology applied to the quality of medicines, a 1.5-day workshop is held. The main focus of the workshop is the discussion of comments received during the public consultation. Stakeholders are therefore encouraged to provide comments well in advance (ideally by the end of November 2017). Stakeholders can express their interest to participate in this workshop by writing to RP-stats-QA@ema.europa.eu. Due to limited spaces, priority will be given to those who provided relevant comments. The output of the workshop will have a direct impact on the finalisation of the reflection paper. ... Read more

  • 14/11/2017

    EMA

    European Medicines Agency information day on measuring the impact of pharmacovigilance activities

    Measuring the impact of pharmacovigilance is essential to allow regulators and pharmaceutical industry to ensure key pharmacovigilance activities are effective and efficient and to support regulatory decisions. Effective risk minimisation balancing benefits and risks of medicines are important tools for patient empowerment and to achieve best public health outcomes. A workshop in 2016 highlighted the need for a sustainable framework, robust scientific methodologies, timely generation of decision-relevant data and clear roles and responsibilities as key pillars of impact research. Based on these recommendations, PRAC is revising its strategy to evaluate EU pharmacovigilance activities in a collaborative approach with clearly defined process indicators and measures of patient health outcomes. At this event stakeholders discuss methodologies for impact research, enablers and barriers to impact, and foster collaboration and sharing of impact relevant information. ... Read more

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