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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.

Latest news

This month's events

December 2014

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  • 18/12/2014 - 18/12/2014 : MB

    Management Board meeting: 18 December 2014

    The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.

  • 15/12/2014 - 18/12/2014 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 15-18 December 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.

  • 11/12/2014 - 12/12/2014 : CAT

    Committee for Advanced Therapies (CAT): 11-12 December 2014

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

  • 10/12/2014 - 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 (ADRs). 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 based on new visualisation technology and analytical methods as well as the safety information on medicines for patients, consumers and healthcare professionals. The workshop aims to identify stakeholder needs and expectations. Registration by invitation only. Places limited.

  • 10/12/2014 - 12/12/2014 : PDCO

    Paediatric Committee (PDCO): 10-12 December 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.

  • 09/12/2014 - 10/12/2014 : COMP

    Committee for Orphan Medicinal Products (COMP): 9-10 December 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.

  • 09/12/2014 - 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. Registration by invitation only.

  • 09/12/2014 - 11/12/2014 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 December 2014

    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.

  • 09/12/2014 - 09/12/2014 : EMA

    European Union clinical trials portal and Union database: Meeting with stakeholders

    In the new European Union (EU) Regulation on clinical trials, the Agency has been made responsible for developing and maintaining the IT platforms that will support sponsors and EU Member State representatives carry out their respective roles related to the submission, assessment and supervision of clinical trials in the EU. The EU clinical trials portal and Union database meetings with stakeholders will be held on various dates to inform the design and development of the systems.

  • 08/12/2014 - 08/12/2014 : EMA

    Medicines and Healthcare Products Regulatory Agency information day: Medical Dictionary for Regulatory Activities in the pharmacovigilance regulatory process

    This information day will provide attendees with a highlight of the latest Medical Dictionary for Regulatory Activities (MedDRA) initiatives and developments. This will includes an outline of various efforts of the MedDRA Maintenance and Support Services Organization (MSSO) to support interoperability of MedDRA with other terminologies specifically in the healthcare domain and the use of MedDRA in coding and analysing medication errors. Places limited.

  • 06/12/2014 - 08/12/2014 : EMA

    The first conference for medicines regulatory authorities in Sudan and neighbouring countries

    Sudan hosted the first conference of medicines regulatory authorities in neighbouring countries from 6 to 8 December 2014, with the participation of representatives of medicines regulatory authorities from Central Africa Republic, Chad, Congo, Egypt, Eritrea, Ethiopia, Jordan, Kenya, Saudi Arabia, South Sudan, Tanzania, and Uganda. The World Health Organization (WHO), the European Medicines Agency (EMA) and the African Union (AU) took part of the event given their role in the regulation and control of medicines. The conference aimed at improving the coordination and cooperation between the neighbouring countries and consequently to promote the unification of medicines legislation between them.

  • 04/12/2014 - 05/12/2014 : EMA

    European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products

    EMA/EFPIA workshop is planned for 4-5 December 2014 to discuss the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products. Registration: please register by 19 September 2014 using the registration form provided.

  • 03/12/2014 - 05/12/2014 : EMA

    EudraVigilance training on the electronic reporting of individual case safety reports (ICSRs) in the European Economic Area

    Participants who pass the knowledge evaluation following the course will receive a notification from the European Medicines Agency (EMA) that will allow them to register with the EudraVigilance and report ICSRs to the EMA and / or the National Authorities in the European Economic Area. Places limited.

  • 01/12/2014 - 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. Registration closed.

  • 01/12/2014 - 04/12/2014 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 1-4 December 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.