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

  • 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

  • 16/04/2015

    EMA

    Micro, small and medium-sized-enterprise (SME) workshop: Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies

    This year's micro, small and medium-sized-enterprise (SME) workshop title 'Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies' aims to provide training on topics such as building quality documentation early during development, manufacturing perspectives, veterinary products, CMC and investigational medicinal product dossiers (IMPDs), and analytical perspectives. Registration by invitation only. Registration open until 20/3/2015. Places limited. ... Read more

  • 09/12/2014

    EMA

    Expert meeting on the clinical investigation of medicines for the treatment of paediatric hepatitis C

    This is an expert meeting on the clinical investigation of medicines for the treatment of paediatric hepatitis C. The aim of the expert meeting is to take up-to-date scientific developments in understanding and treating hepatitis C into consideration when discussing Paediatric Development Plans and to discuss how the therapeutic needs for paediatric hepatitis C can be better addressed. This will also include discussions on how to facilitate paediatric drug development. ... Read more

  • 18/03/2015

    EMA

    Science, Medicines, Health: Patients at the heart of future innovation conference

    The invitation-only conference is organised to celebrate the 20th anniversary of the European Medicines Agency. Looking back at the past two decades, the Agency is proud of its successes, impressive growth and achievements. Yet, in addition to celebrating past successes, the Agency has its eyes firmly set in the challenges of the future. Cognisant of its pivotal role at the crossroads of life science research and development, patient care, public health policy and law, the Agency will use this event to explore with a range of stakeholders how best to deliver its role in the future. ... Read more

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