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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

September 2016

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  • 28/09/2016 - 30/09/2016 :

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

    This training course covers all aspects on the functionalities of the EudraVigilance system, specifically EVWEB, the web interface tool for the electronic reporting of ICSRs, with practical examples and exercises in the EudraVigilance training environment. The training will include the fundamentals of electronic transmission of ICSRs and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications as well as the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and the current EudraVigilance business rules.

  • 26/09/2016 - 29/09/2016 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2016

    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.

  • 26/09/2016 - 27/09/2016 : EMA

    eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course

    The eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course aims to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union and European Economic Area countries. The training focuses on explaining provided guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicines, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicines.

  • 21/09/2016 - 21/09/2016 : EMA

    Ninth industry stakeholder platform - operation of EU pharmacovigilance

    The ninth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system will take place at the EMA on 21 September 2016. Discussions will include GVPs, public hearings and pharmacovigilance impact.

  • 21/09/2016 - 21/09/2016 : EMA

    Tenth 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.

  • 21/09/2016 - 23/09/2016 : EMA

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

    This training course covers all aspects on the functionalities of the EudraVigilance system, specifically EVWEB, the web interface tool for the electronic reporting of ICSRs, with practical examples and exercises in the EudraVigilance training environment. The training will include the fundamentals of electronic transmission of ICSRs and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications as well as the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and the current EudraVigilance business rules.

  • 20/09/2016 - 20/09/2016 : EMA

    European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting

    This joint PCWP/HCPWP meeting will include the election of the PCWP and HCPWP co-chairs for the 2016 – 2019 mandate. Personalised medicines will be discussed and participants will be updated on the PCWP/HCPWP topic groups; the 2017 work programme; the framework of collaboration with academia; and feedback will be given from the scientific committees.

  • 19/09/2016 - 20/09/2016 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 19-20 September 2016

    The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency’s opinions on questions relating to herbal medicines.

  • 19/09/2016 - 19/09/2016 : EMA

    EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Workshop on social media

    This joint PCWP/HCPWP workshop on social media is being held to discuss the challenges and practical applications of social media and their impact on regulators, healthcare professionals and patients. The objectives are to provide an overview of what social media are and what they are being used for in the context of medicines regulation; share healthcare professionals’, patients’ and regulators’ practices on how social media is used to amplify communication on medicines information and regulatory outputs; discuss how social media is being used for gathering medicine-related data; reflect on how communication and data gathering through social media may influence behaviours and attitudes towards medicines information and medicines use, impact regulatory decisions, and shape interactions with stakeholders; and to identify areas requiring action from regulators, patients and healthcare professionals.

  • 16/09/2016 - 16/09/2016 : EMA

    First European Medicines Agency - European Federation of Pharmaceutical Industries and Associations annual bilateral meeting

    This meeting between European Medicines Agency (EMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) is being organised in the context of the EMA annual bilateral meetings with Industry stakeholder organisations. The purpose of the meeting is to exchange views and promote dialogue on topics of common interest.

  • 14/09/2016 - 16/09/2016 : PDCO

    Paediatric Committee (PDCO): 14-16 September 2016

    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.

  • 13/09/2016 - 13/09/2016 : EMA

    Medical literature monitoring workshop

    The medical literature monitoring workshop is an opportunity for Marketing Authorisation Holders (MAHs) to help shape possible future changes to the medical literature monitoring service. The EMA and industry discuss challenges faced by MAHs regarding the medical literature monitoring service and how the service could be amended in the future to ameliorate these.

  • 12/09/2016 - 13/09/2016 : EMA

    Second annual scientific workshop at EMA: Applying regulatory science to neonates

    This workshop is co-sponsored by the EMA and the Critical Path Institute. It focuses on reviewing the progress and exploring new initiatives for the International Neonatal Consortium (INC), which is dedicated to accelerating the development of safe and effective therapies for neonates. One cross-cutting topic is how to enhance a research culture. Other overarching topics are precision medicine for neonates and long-term outcome measures. Therapeutic areas that will be examined include Neonatal Abstinence Syndrome (NAS) and Necrotizing Enterocolitis (NEC).

  • 12/09/2016 - 15/09/2016 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 12-15 September 2016

    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.

  • 08/09/2016 - 09/09/2016 : CAT

    Committee for Advanced Therapies (CAT): 8-9 September 2016

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

  • 06/09/2016 - 08/09/2016 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 September 2016

    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.

  • 06/09/2016 - 08/09/2016 : COMP

    Committee for Orphan Medicinal Products (COMP): 6-8 September 2016

    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.

  • 30/08/2016 - 02/09/2016 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 30 August - 2 September 2016

    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.