Event and meeting calendar

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Search for all of the European Medicines Agency' events, including workshops, symposia and meetings of the Agency's Management Board and scientific committees.

Committee and Management Board meetings only display from the year 2010.  

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November 2017

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  • 2017-11-30 - 2017-12-01 : EMA

    Data anonymisation workshop

    The data anonymisation workshop focuses on anonymisation as a key enabler for clinical data sharing. The scope of the workshop includes clinical trial data including individual patient level data and real world data in the context of patient registries and individual cohort studies.

  • 2017-11-29 - 2017-11-30 :

    Innovation and biomarkers in cancer drug development (IBCD) 2018

    The innovation and biomarkers in cancer drug development (IBCD) 2018 event will embrace the full environment and explore routes through the constantly evolving scientific, methodological and regulatory environment. The combined efforts of the European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI), European Medicines Agency (EMA), and American Association for Cancer Research (AACR) with the involvement of Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) and health technology assessment specialists will result in a unique program. The 2018 edition will build upon the recommendations and action points decided upon at the IBCD 2016 edition. Topics, which will be developed, will include items like health technology assessment (HTA) of biomarker assays, comparative effectiveness research and the translation of findings of clinical trials into daily practice.

  • 2017-11-27 - 2017-11-30 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 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.

  • 2017-11-27 - 2017-11-29 : 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.

  • 2017-11-24 - 2017-11-25 : EMA

    Third tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents

    This meeting built on the work of previous two meetings between the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the way these regulators approach the evaluation of antimicrobials, aiming at identifying further areas for convergence. The three agencies agreed to further align how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea or uncomplicated urinary tract infections. They also committed to working together to explore how to better streamline paediatric development of new antibacterial agents and discussed he importance of characterising the pharmacokinetic-pharmacodynamic relationship and monitoring the benefit-risk balance throughout the medicine lifecycle. The agencies plan to meet again in 2018.

  • 2017-11-23 - 2017-11-23 : CHMP

    Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications

    The term ‘prior knowledge’ can refer to both a company’s proprietary knowledge of formulation and manufacturing development of medicinal products and external knowledge from published scientific literature. The use of such prior knowledge to support the development of product formulations, manufacturing processes and control strategies, could be justifiable in certain circumstances. Through a combination of presentations, industry case studies and panel discussions, this joint workshop with regulators and the pharmaceutical industry aims to reach an agreed understanding on what is (and isn’t) considered to be prior knowledge, how can such prior knowledge be used in regulatory submissions, how to justify its use and how to present it in the dossier. EMA will publish a report with conclusions from the workshop. It may also consider further follow-up guidance.

  • 2017-11-23 - 2017-11-24 :

    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.

  • 2017-11-22 - 2017-11-22 : EMA

    European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting with all eligible organisations

    This final meeting for 2017 brings together members of the Patients and Consumers Working Party (PCWP) with all eligible patient and consumer organisations. Topics for discussion include highlights from 2017, feedback on EMA’s first public hearing, some new EMA shareable communications, big data and real world evidence, EMA Action Plan following Commission’s recommendations on product information and EMA’s new EPAR summary template. Other topics for discussion include the PCWP and HCPWP work plans and topic groups for 2018/19, scientific committees’ feedback and Members’ voice. Participants will also be updated on relocation preparedness.

  • 2017-11-21 - 2017-11-21 : EMA

    Training session for patients and consumers interested in European Medicines Agency activities

    This one-day training session for representatives of patients' and consumers' and healthcare professionals’ organisations aims at presenting an overview of medicines evaluation with specific emphasis on where and how they can be involved. Using a hands-on interactive approach, participants will learn more about how they can contribute to scientific advice procedures, Scientific Advisory Group (SAG) meetings and in review of information for patients.

  • 2017-11-20 - 2017-11-21 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 20-21 November 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.

  • 2017-11-20 - 2017-11-22 : 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.

  • 2017-11-17 - 2017-11-17 : EMA

    SME info day: supporting innovative medicines' development and early access

    The info day provides an overview of EU initiatives supporting development stage small and medium-sized enterprises in the human medicines field. It highlights future EU funding opportunities and platforms for early regulatory dialogue with the European Medicines Agency (EMA) and the EU network. It covers recent developments in scientific advice, the range of support that companies can access to optimise their development plans, and feedback on experience at stage of the marketing authorisation. It is organised in collaboration with the newly launched EU Innovation Network, a platform created to support pharmaceutical innovation both at national and EU level. In the breaks the “Meet the EU Innovation Network Regulators” event will provide an opportunity to engage with its representatives. An update on Brexit related activities will also be provided. The info day is open to companies that have been assigned an SME status by EMA and to representatives of stakeholder organisations.

  • 2017-11-15 - 2017-11-15 : EMA

    Second industry stakeholder platform on research and development support

    This is the second event in a series of (semi-)annual meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of product development support, from scientific advice, over specifics for paediatric and orphan medicines and to innovation support. This platform 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. Registration by invitation only.

  • 2017-11-15 - 2017-11-17 :

    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.

  • 2017-11-14 - 2017-11-14 : EMA

    European Medicines Agency information day on measuring the impact of pharmacovigilance activities

    Measuring the impact of pharmacovigilance is essential to allow regulators and pharmaceutical industry to ensure key pharmacovigilance activities are effective and efficient and to support regulatory decisions. Effective risk minimisation balancing benefits and risks of medicines are important tools for patient empowerment and to achieve best public health outcomes. A workshop in 2016 highlighted the need for a sustainable framework, robust scientific methodologies, timely generation of decision-relevant data and clear roles and responsibilities as key pillars of impact research. Based on these recommendations, PRAC is revising its strategy to evaluate EU pharmacovigilance activities in a collaborative approach with clearly defined process indicators and measures of patient health outcomes. At this event stakeholders discuss methodologies for impact research, enablers and barriers to impact, and foster collaboration and sharing of impact relevant information.

  • 2017-11-13 - 2017-11-14 : PDCO

    Second paediatric strategy forum on medicine development for mature B cell malignancies in children

    This second multi-stakeholder paediatric strategy forum, jointly organised by ACCELERATE and the European Medicines Agency, will focus on mature B cell malignancies (lymphoma and leukaemia) in children. The goal of this meeting is to share information, in a pre-competitive setting, which will inform a paediatric drug development strategy and subsequent decisions and facilitate the developments of innovative medicines for the treatment of children with mature B cell malignancies. Participation is restricted and on invitation only. Interested parties, including patients and parent-representatives, academia, clinicians and industry, should express their interest. For clinicians and researchers, priority will be given to those who have expertise and experience in clinical trials for mature B cell malignancies in children or intend to design such studies in the future.

  • 2017-11-08 - 2017-11-10 : 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.

  • 2017-11-07 - 2017-11-10 : PDCO

    Paediatric Committee (PDCO): 7-10 November 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.

  • 2017-11-07 - 2017-11-09 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 November 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.

  • 2017-11-06 - 2017-11-09 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 6-9 November 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.

  • 2017-11-06 - 2017-11-08 : EMA

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

    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.

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