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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

April 2015

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  • 30/04/2015 - 30/04/2015 : EMA

    European Medicines Agency (EMA)/European Generic medicines Association joint workshop on the impact of the revised EMA guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms

    The workshop provides a platform to discuss the impact of the revised European Medicines Agency guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms. It aims at fostering a common understanding and interpretation of regulatory expectations before 1 June 2015, when the guideline comes into effect. Places limited. Registration open until 22 April 2015.

  • 30/04/2015 - 30/04/2015 : EMA

    European Medicines Agency (EMA)/European Society for Medical Oncology (ESMO) Rare Cancers Europe initiative: Joint workshop on chordoma as a model for very rare cancers

    Following the workshop on the methodology of clinical trials in rare cancers held in October 2014, the European Medicines Agency (EMA) and the European Society for Medical Oncology (ESMO) Rare Cancers Europe initiative will review a real case scenario on one single rare cancer and discuss together how to facilitate the development of promising therapies in spite of rarity. The aim of this workshop, which focuses on chordoma, is to discuss scientific and regulatory evidence requirements for rare diseases, main challenges and identify possible methodological solutions that could work for this and other very rare cancers. The meeting foresees the participation of oncologists, statisticians, methodologists, patient advocates and industry. A meeting report will be published on the EMA and ESMO websites. Registration by invitation only. Places limited.

  • 29/04/2015 - 29/04/2015 : EMA

    Individual case safety report information day

    This information day will address and explain the key changes expected in relation to the application of the new International Organization for Standardization (ISO) individual case safety report standard and how this will impact the European Union adverse reaction reporting and electronic transmission activities. Places limited.

  • 28/04/2015 - 28/04/2015 : EMA

    Information day on new services and systems in pharmacovigilance: preparing for business change

    This information day is primarily aimed at providing marketing-authorisation holders (MAHs) with information to help prepare for the business change to come,focusing on the most critical questions: what needs to be done and by when. Places limited.

  • 24/04/2015 - 24/04/2015 : EMA

    New industry stakeholder platform on the operation of the centralised procedure

    This is the first event in a series of upcoming, semi-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 meeting is providing an update on the current operations, achievements so far, and planned improvements. Particular focus is on the interface in interactions with the applicant during evaluation procedures as well as the management of variations. Registration by invitation only. Registration closed.

  • 23/04/2015 - 24/04/2015 : 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 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data-entry tool EVWEB. It includes exercises in the XEVPRM data-entry for the electronic submission and maintenance of different types of medicinal products. Places limited.

  • 20/04/2015 - 23/04/2015 : CHMP

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

  • 20/04/2015 - 22/01/2015 : 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.

  • 16/04/2015 - 16/04/2015 : EMA

    Micro-, small- and medium-sized-enterprise (SME) workshop: Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies

    This year's micro-, small- and medium-sized-enterprise (SME) workshop title 'Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies' aims to provide training on topics such as building quality documentation early during development, manufacturing perspectives, veterinary products, CMC and investigational medicinal product dossiers (IMPDs), and analytical perspectives. Registration by invitation only. Registration open until 20/03/2015. Places limited.

  • 16/04/2015 - 17/04/2015 : CAT

    Committee for Advanced Therapies (CAT): 16-17 April 2015

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

  • 15/04/2015 - 17/04/2015 : PDCO

    Paediatric Committee (PDCO): 15-17 April 2015

    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.

  • 14/04/2015 - 16/04/2015 : COMP

    Committee for Orphan Medicinal Products (COMP): 14-16 April 2013

    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.

  • 08/04/2015 - 10/04/2015 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 April 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.

  • 07/04/2015 - 10/04/2015 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 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.