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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March 2017

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  • 2017-03-29 - 2017-03-30 : EMA

    Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop

    The European Union funds three projects, Asterix, IDeAl and InSPiRe, within the Seventh Framework Programme (FP7) to develop new methodology on design and analysis of small population clinical trials since 2013. The projects are in their final phase. The workshop will discuss their results to date. The aim is to translate and promote results and novel methodologies into tangible recommendations to advance the clinical research and development of medicines and new treatments for patients with a rare disease and personalised medicine. The results to date and draft recommendations for application will be discussed by international representatives of patient organisations, pharmaceutical industry, academic statisticians and clinical trial methodologists, clinical researchers, pharmaceutical industry and regulators.

  • 2017-03-28 - 2017-03-28 : EMA

    Workshop on revising the guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicines

    The European Medicines Agency (EMA) held a public consultation a concept paper which outlined the major areas for revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’, from July to September 2016. Subsequently, EMA published a draft revised guideline for public consultation, from November 2016 to February 2017. This technical workshop aims to finalise the guidance with further involvement of stakeholders including from other regulatory agencies, pharmaceutical industry, contract research organisations and academia. The focus of the workshop will be on discussing comments received during the public consultations, therefore participation of external stakeholders is limited to those individuals and organisations who submitted comments. The output of the workshop will be reflected in the final revised guideline and the published overview of comments.

  • 2017-03-27 - 2017-03-28 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 27-28 March 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.

  • 2017-03-23 - 2017-03-24 : EMA

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

    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.

  • 2017-03-21 - 2017-03-24 : PDCO

    Paediatric Committee (PDCO): 21-24 March 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.

  • 2017-03-20 - 2017-03-20 : EMA

    SME info day on the new clinical trial regulation

    This SME info day provides an overview on the key features and objectives of the new clinical trial regulation. It also covers the future clinical trial authorisation process, the functionalities of the EU CT portal and database, transparency aspects of the new regulation and safety reporting requirements. The event is for companies that have been assigned SME status by the EMA and representatives of stakeholder organisations.

  • 2017-03-20 - 2017-03-23 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 20-23 March 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.

  • 2017-03-20 - 2017-03-22 :

    EudraVigilance training on electronic reporting of ICSRs in the EEA

    This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB with regard to electronic reporting of ICSRs including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and 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.

  • 2017-03-16 - 2017-03-17 : CVMP

    European Medicines Agency veterinary medicines info day

    The European Medicines Agency veterinary medicines info day, organised in collaboration with International Federation for Animal Health Europe (IFAH-Europe), provides first-hand information on the latest developments in the scientific review, regulation and marketing authorisation procedure in the field of veterinary medicine regulation. For the first time, this year, European Medicines Agency (EMA) will have dedicated information points on esubmissions, veterinary application submissions and veterinary medicines innovation.

  • 2017-03-16 - 2017-03-16 : MB

    Management Board meeting: 16 March 2017

    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.

  • 2017-03-15 - 2017-03-17 : CAT

    Committee for Advanced Therapies (CAT): 15-17 March 2017

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

  • 2017-03-15 - 2017-03-15 : EMA

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

    This joint PCWP/HCPWP meeting will discuss the European Medicines Agency's (EMA) 2016 annual report 2016, its interactions with patients, consumers, healthcare professionals and their organisations, its work plans for 2018/19, the outcome of the Committee for Medicinal Products for Human Use pilot project, European Antibiotic Awareness Day. It will also provide an update on topic groups including biosimilars, the 10 year report on conditional marketing authorisations, regulators’ and health technology assessment bodies’ related activities and feedback from the scientific committees.

  • 2017-03-14 - 2017-03-14 : EMA

    Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines

    The joint PCWP/HCPWP workshop on personalised medicines aims to create awareness among patient, consumer and healthcare professional organisations of how the work of the European Medicines Agency (EMA) relates to this topic. The working parties will also reflect on priority areas for future contributions in broader multi-stakeholder discussions. The objectives of the workshop include understanding how European and global landscapes are shaping policy developments, illustrating how activities of the European medicines regulatory network contribute to personalised medicine with existing legislation and regulatory tools, discussing how clinical practice and public participation can support personalised medicine in the context of European Union (EU) regulatory activities and identifying areas requiring attention from EU regulators, patients, healthcare professionals and civil society at large. EMA will publish the presentations, video recording and a workshop report.

  • 2017-03-14 - 2017-03-15 : COMP

    Committee for Orphan Medicinal Products (COMP): 14-15 March 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.

  • 2017-03-14 - 2017-03-16 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 March 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.

  • 2017-03-10 - 2017-03-10 : EMA

    European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting

    The European Union (EU) International Organisation for Standardization (ISO) identification of medical products (IDMP) / Substance, Product, Organisation and Referential (SPOR) data Task Force meeting with representatives from the European Medicines Agency, national competent authorities, pharmaceutical industries associations, terminology organisations, software vendors and developers of medicinal products dictionaries / databases will discuss aspects of planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.

  • 2017-03-08 - 2017-03-08 : EMA

    Online training course for bioequivalence inspectors

    The online training course provides good clinical practice inspectors in the European Union general information on bioequivalence to help them develop the necessary knowledge and skills to inspect bioequivalence studies.

  • 2017-03-06 - 2017-03-09 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 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.

  • 2017-03-06 - 2017-03-08 : EMA

    EudraVigilance training on electronic reporting of ICSRs in the EEA

    This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB with regard to electronic reporting of ICSRs including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and 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.

  • 2017-03-02 - 2017-03-03 : EMA

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

    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.

  • 2017-02-27 - 2017-03-01 : EMA

    EudraVigilance training on electronic reporting of ICSRs in the European Economic Area

    This training course covers all aspects on the functionalities of the EudraVigilance system specifically 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 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.

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