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This section of the website contains the European Medicines Agency's news and press releases, information on meetings and events, public consultations and related information.

For a scrolling feed of all of the new and updated information published on the website, see the what's new page.

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This month's events

April 2014

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  • 29/04/2014 - 29/04/2014 : EMA

    Second periodic safety update report information day

    This information day provides a forum to discuss the implementation experience with periodic safety update reports (PSURs) under the new pharmacovigilance legislation from a European Union, international-regulator and pharmaceutical-industry perspective. This includes the first practical experience with the recently started single PSUR assessment for centrally and nationally authorised medicinal products. Places limited.

  • 23/04/2014 - 25/04/2014 : PDCO

    Paediatric Committee (PDCO): 23-25 April 2014

    The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.

  • 22/04/2014 - 25/04/2014 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 22-25 April 2014

    The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.

  • 15/04/2014 - 16/04/2014 : CAT

    Committee for Advanced Therapies (CAT): 15-16 April 2014

    The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

  • 08/04/2014 - 10/04/2014 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 April 24

    The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.

  • 08/04/2014 - 09/04/2014 : COMP

    Committee for Orphan Medicinal Products (COMP): 08-09 April 2014

    The Committee for Orphan Medicinal Products (COMP) is the committee that is responsible for reviewing applications for 'orphan medicinal product designation' for medicines intended for the diagnosis, prevention or treatment of rare diseases.

  • 07/04/2014 - 10/04/2014 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2014

    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.

  • 04/04/2014 - 04/04/2014 : EMA

    SME workshop for micro, small and medium-sized enterprises: Focus on quality for medicines containing chemical entities

    Workshops for micro, small and medium-sized enterprises (SME) take place at the European Medicines Agency (EMA) annually, and have been organised by the SME Office since 2007. This year we have initiated a workshop with a focus on quality aspects for chemical entities. Topics to be covered include building quality documentation early during development, scientific advice on quality aspects, considerations for veterinary medicines and innovations and emerging topics in pharmaceutical developments. The workshop is open to companies that have been assigned SME status by the EMA and to representatives of stakeholder organisations.