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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 2017

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  • 2017-09-27 - 2017-09-29 : EMA

    The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    The European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2017-09-25 - 2017-09-29 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 25-29 September 2017

    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.

  • 2017-09-22 - 2017-09-22 : EMA

    PSUR roadmap: joint industry/assessor training

    This joint industry and national competent authority assessors’ training aims to achieve a common understanding of the role of periodic safety assessment reports (PSUR) in the product lifecycle and of the European Union (EU) PSUR single assessment. It is part of the PSUR roadmap activities and will identify key issues encountered by industry and regulators in the preparation of PSURs and share best practices on ways to address them. The webinar will be in the form of a question-and-answer (Q&A) session led by a joint panel of industry and regulators. It will cover the following topics described in the explanatory note to good pharmacovigilance practice (GVP) module VII and the PSUR Q&A for assessors: signals and close monitoring, safety specification, product information / reference safety information and use of summary tabulations. No prior registration is required. Please send questions on any topic to assessors and industry speakers to psurtraining@ema.europa.eu

  • 2017-09-22 - 2017-09-22 :

    Follow up information session on the TransCelerate initiative

    The meeting provides an opportunity for TransCelerate to update the European Medicines Agency on progress with ongoing initiatives and new areas of work, which focuses on the development of practical solutions to overcome inefficiencies in clinical trials.

  • 2017-09-21 - 2017-09-22 : EMA

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

    This eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course has been prepared 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 (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, 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 medicinal products.

  • 2017-09-21 - 2017-09-21 : EMA

    Eleventh 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.

  • 2017-09-20 - 2017-09-20 : EMA

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

    This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include discussions on the work plans for 2018/19; a proposal for revision of PCWP/HCPWP mandates and rules of procedure; a proposal for streamlining the process for re-assessment of eligibility status, compassionate use of medicines; Participants will also be updated on European Medicines Agency (EMA) preparedness on Brexit; the upcoming public hearing; the next steps on the potential actions following the European Commission (EC) report on product information. Other topics for discussion include the scientific committees’ feedback and Members’ voice.

  • 2017-09-19 - 2017-09-19 : EMA

    EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: info session on antimicrobial resistance

    The joint Patients' and Consumers' Working Party (PCWP) / Healthcare Professionals' Working Party (HCPWP) meeting on antimicrobial resistance aims to raise awareness of the work of European Union institutions, Member States and World Health Organization in the fight against antimicrobial resistance. It will also explain how the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control can support the European- and global-level fight against antimicrobial resistance. The meeting will also stimulate an exchange of ideas with patients and consumer and healthcare professional organisations on how to join efforts for improving communication, education and training in the fight against antimicrobial resistance.

  • 2017-09-19 - 2017-09-19 : EMA

    EudraVigilance information day

    EudraVigilance information day provides a forum to discuss the final steps in preparation of the simplified adverse reaction reporting, the new signal management for marketing authorisation holders in the European Economic Area (EEA) as well as the initial testing experience by stakeholders. More specifically, the focus of this information day will be on the EudraVigilance go-live planning and the preparations and actions required by national competent authorities in the EEA, marketing authorisation holders and sponsors of clinical trials. The information day will also serve as a platform to experts to share their testing experience based on the use of the new EudraVigilance XCOMP (test) environment, which was released on 26 June 2017 and to raise specific process related and technical questions.

  • 2017-09-18 - 2017-09-19 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 18-19 September 2017

    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.

  • 2017-09-18 - 2017-09-19 : EMA

    Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations

    This two-day awareness session is for international regulators and non-governmental organisations. It gives an insight into the European Union (EU) regulatory system for medicines and the role of the European Medicines Agency (EMA). Insight into the EU system is of prime importance in an increasingly globalised world where worldwide regulators rely on close cooperation. The EU system is one of the most advanced in the world, but it is also one of the most complex. It is based on a network of decentralised agencies in the EU Member States, supported and coordinated by EMA.

  • 2017-09-18 - 2017-09-20 : EMA

    The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    The European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2017-09-13 - 2017-09-15 : EMA

    The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    The European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2017-09-12 - 2017-09-15 : PDCO

    Paediatric Committee (PDCO): 12-15 September 2017

    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.

  • 2017-09-11 - 2017-09-13 : EMA

    The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    The European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2017-09-11 - 2017-09-14 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2017

    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.

  • 2017-09-06 - 2017-09-06 : CVMP

    CVMP interested parties' meeting

    The CVMP will be holding an interested parties meeting as part of regular stakeholder liaison. Topics for discussion this year will include antimicrobials resistance (AMR), persistent, bioaccumulative and toxic (PBT) assessments, quality guidelines on veterinary medicines, the Pilot Project on the Harmonisation and Optimisation of Veterinary Antimicrobials (PPHOVA), update on 3Rs (replacement, reduction and refinement) activities and Brexit preparedness.

  • 2017-09-06 - 2017-09-08 : CAT

    Committee for Advanced Therapies (CAT): 6-8 September 2017

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

  • 2017-09-06 - 2017-09-08 :

    The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    The European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2017-09-05 - 2017-09-07 : COMP

    Committee for Orphan Medicinal Products (COMP): 5-7 September 2017

    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.

  • 2017-09-05 - 2017-09-07 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 September 2017

    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.

  • 2017-09-04 - 2017-09-06 : EMA

    The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course

    The European Medicines Agency (EMA) will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the individual case safety report (ICSR) standards developed by the International Organization for Standardization (ISO), in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

  • 2017-08-29 - 2017-09-01 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 29 August-1 September 2017

    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.