Pharmaceutical industry

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On this page, you will find information on the Agency’s activities that are most relevant to pharmaceutical industry, including news, and events.

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Events of interest

  • 11/06/2018 - 14/06/2018

    PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018

    The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use. ... Read more

  • 14/05/2018 - 17/05/2018

    PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018

    The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use. ... Read more

  • 05/03/2018 - 08/03/2018

    PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018

    The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use. ... Read more

  • 01/12/2014

    EMA

    Workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'

    The Quality Working Party is organising a workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'. The guideline has been in force as of February 2014 and is intended to provide additional guidance to pharmaceutical developers on quality aspects related to medicinal products for children between birth and 18 years of age. As more experience becomes available, further work is required to complement the guideline with additional recommendations on pharmaceutical development of paediatric medicines. The general scope of this workshop is to share the experience gained so far with the use of the guideline among stakeholders (regulators, healthcare professionals, academia and industry) and identify gaps in current knowledge. This workshop should be considered as a starting point for discussions. ... Read more

  • 10/12/2014

    EMA

    Innovative Medicines Initiative WEB-RADR workshop

    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

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