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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

May 2015

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  • 28/05/2015 - 29/05/2015 : EMA

    Annual workshop of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)

    Day one of the workshop, 28 May, is an open meeting to all stakeholders: patient/parent organisations, network representatives, pharmaceutical industry staff responsible for paediatric studies and regulators. Day two, 29 May, is dedicated to members of Enpr-EMA and its Coordinating Group. Registration is open until 15 May 2015 using the registration form.

  • 20/05/2015 - 22/05/2015 : EMA

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

    This training course covers all aspects of the functionalities of the EudraVigilance system, specifically the data-entry tool EVWEB, with regard to electronic reporting of individual case safety reports (ICSRs), including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and International Conference on Harmonisation (ICH) M2 safety and acknowledgment message specifications, as well as ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and current EudraVigilance business rules. Places limited.

  • 20/05/2015 - 22/05/2015 : PDCO

    Paediatric Committee (PDCO): 20-22 May 2015

    The Paediatric Committee (PDCO) is the committee responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children. This also includes assessing applications for full or partial waivers and applications for deferrals.

  • 19/05/2015 - 19/05/2015 : EMA

    Introduction to pharmacovigilance and rules for expedited reporting of individual case safety reports in Europe

    This one day course covers the pre-requisites for the three day training course on EudraVigilance – electronic reporting of individual case safety reports (ICSRs) and is therefore recommended to newcomers in pharmacovigilance, in particular individuals dedicated to data entry and expedited reporting. The attendees will learn about the essentials of pharmacovigilance, the format, structure and content of ICSRs as well as the rules for expedited reporting in Europe for both clinical trials and post-marketing ICSRs. Places limited.

  • 18/05/2015 - 21/05/2015 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 18-21 May 2015

    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.

  • 18/05/2015 - 19/05/2015 : EMA

    Applying regulatory science to neonates: launch of the International Neonatal Consortium (INC)

    The International Neonatal Consortium is a coalition of industry, academia, patient representatives, the Food and Drug Administration, the European Medicines Agency, other governmental agencies, foundations, professional organizations, and the Critical Path Institute (C-Path) that will focus on accelerating the development of therapeutics for the neonatal population. At this workshop, participants will prioritise projects and initiate collaborations to develop safe and effective treatments for neonates. Registration open until 11 May 2015.

  • 12/05/2015 - 13/05/2015 : CAT

    Committee for Advanced Therapies (CAT): 12-13 May 2015

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

  • 12/05/2015 - 13/05/2015 : COMP

    Committee for Orphan Medicinal Products (COMP): 12-13 May 2015

    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.

  • 11/05/2015 - 11/05/2015 : EMA

    European Medicines Agency-industry stakeholders platform meeting on paediatric medicines

    The European Medicines Agency (EMA) is hosting the first meeting of a new industry stakeholder platform on paediatric procedures. This is the first in a series of upcoming annual meetings between regulators and representatives of industry stakeholder organisations. It aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. The first meeting is providing an update on the current operations, achievements so far, and planned improvements. Particular focus is on the class waiver list review, the early interaction process, public summaries and paediatric investigation plan (PIP) compliance check during validation. Registration closed.

  • 06/05/2015 - 06/05/2015 : CVMP

    CVMP interested parties’ meeting

    The CVMP will be holding an interested parties meeting as part of regular stakeholder liaison. Subjects for discussion will include pharmacovigilance, environmental risk assessment, SPC harmonisation and measures taken to promote the 3 Rs (replacement, reduction and refinement). Registration by invitation only.

  • 05/05/2015 - 07/05/2015 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 May 2015

    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.

  • 04/05/2015 - 07/05/2015 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 May 2015

    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.

  • 04/05/2015 - 06/05/2015 : EMA

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

    This training course covers all aspects of the functionalities of the EudraVigilance system, specifically the data-entry tool EVWEB, with regard to electronic reporting of individual case safety reports (ICSRs), including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and International Conference on Harmonisation (ICH) M2 safety and acknowledgment message specifications, as well as ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and current EudraVigilance business rules. Places limited.

  • 04/05/2015 - 05/05/2015 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 4-5 May 2015

    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.