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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

October 2016

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  • 28/10/2016 - 28/10/2016 : EMA

    Periodic safety update report information day

    This information day provides a forum to discuss ongoing activities and status of periodic safety update report (PSUR) single assessment procedures, with a particular emphasis on the PSUR roadmap and how it supports reaching a common understanding of the single assessment. The roadmap is key to optimising the process and content of PSURs and the EU single assessment (PSUSA). The information day will also look into the procedural improvements that are already implemented and discuss further improvements based on views from the pharmaceutical industry. The event will also provide an opportunity for industry, EMA and national competent authorities to share experiences on the mandatory use of the PSUR repository lessons learned from the transition. It will also outline the role of PSURs in inspections from inspectors’ and industry’s point of view.

  • 28/10/2016 - 28/10/2016 : EMA

    Patient registries workshop

    Through the Patient Registry Initiative launched in September 2015, the EMA aims to facilitate interactions between registry co-ordinators and potential users of registry data both at an early stage of the development, during the marketing authorisation evaluation procedure and post-authorisation. This workshop is designed to bring together multiple stakeholders including registry owners, industry, HTA representatives and regulators to discuss the challenges and barriers to collaboration and identify specific solutions. More specifically the workshop aims to: - Identify the challenges faced by registries and industry when collaborating; - Understand the technical challenges presented by disparate datasets; - Identify concrete solutions to better facilitate relations to avoid duplication.

  • 24/10/2016 - 27/10/2016 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2016

    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.

  • 20/10/2016 - 20/10/2016 : EMA

    Information day on medication errors

    Medication errors are a major public health burden and error prevention is a shared responsibility between patients, healthcare professionals, regulators and pharmaceutical industry at all levels of healthcare delivery. This information day is an opportunity for pharmaceutical industry and regulatory agencies to exchange experience on the new European Union (EU) good practice guide on medication errors published by the European regulatory network in 2015. The objective is to raise awareness of EU pharmacovigilance obligations for medication errors and to discuss operational aspects and good practice recommendations with regard to medication error reporting, evaluation and prevention, with insight into the current regulatory thinking on how to tackle medication errors within health care delivery systems for the benefit of patient safety.

  • 20/10/2016 - 21/10/2016 : EMA

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

    The eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course aims 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 and European Economic Area countries. The training focuses on explaining provided guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicines, 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 medicines.

  • 19/10/2016 - 19/10/2016 : EMA

    Innovative Medicines Initiative WEB-RADR workshop: mobile technologies and social media as new tools in pharmacovigilance

    The Innovative Medicines Initiative (IMI) WEB-RADR project aims to explore the use of mobile technologies and social media to further improve the collection and analysis of information on the suspected adverse drug reactions. This includes the use of mobile apps to report adverse reactions, the possibility identifying potential safety issues with medicines from user comments (posts) on social media as well as the safety information on medicines. The second workshop provides an opportunity to engage with consumers, patients, healthcare professionals and medicines regulatory authorities to discuss latest developments and to obtain input and feedback to maximise the utility and benefits of the project deliverables.

  • 17/10/2016 - 19/10/2016 : EMA

    Training on electronic reporting of individual case safety reports (ICSRs) to EudraVigilance in the European Economic Area

    This training course covers all aspects on the functionalities of the EudraVigilance system, specifically EVWEB, the web interface tool for the electronic reporting of ICSRs, with practical examples and exercises in the EudraVigilance training environment. The training will include the fundamentals of electronic transmission of ICSRs and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications as well as the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and the current EudraVigilance business rules.

  • 12/10/2016 - 14/10/2016 : PDCO

    Paediatric Committee (PDCO): 12-14 October 2016

    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.

  • 10/10/2016 - 13/10/2016 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2016

    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.

  • 10/10/2016 - 11/10/2016 : EMA

    Joint DIA/EFGCP/EMA better medicines for children conference 2016 on optimisation of drug development for the benefit of children

    The conference will discuss how drug development can be further optimised to the benefit of children’s health. This will include a discussion on lessons learned during the years of full operation of the European Union (EU) Paediatric Regulation, new concepts and strategies for an integrated approach at each and every step of paediatric development and sessions dedicated to specific areas of expertise such as neonatology as well as evolving concepts such as the approach to extrapolation from adult data. On day one participants will discuss more specialised and hot topic issues in five breakout sessions. Day two will discuss the holistic integrated approach and global issues. This event is organised by European Forum for Good Clinical Practice (EFGCP), with the partnership of Drug Information Association (DIA) and European Medicines Agency (EMA).

  • 05/10/2016 - 07/10/2016 : EMA

    Training on electronic reporting of individual case safety reports (ICSRs) to EudraVigilance in the European Economic Area

    This training course covers all aspects on the functionalities of the EudraVigilance system, specifically EVWEB, the web interface tool for the electronic reporting of ICSRs, with practical examples and exercises in the EudraVigilance training environment. The training will include the fundamentals of electronic transmission of ICSRs and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications as well as the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and the current EudraVigilance business rules.

  • 05/10/2016 - 07/10/2016 : CAT

    Committee for Advanced Therapies (CAT): 5-7 October 2016

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

  • 05/10/2016 - 06/10/2016 : MB

    Management Board meeting: 5-6 October 2016

    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.

  • 04/10/2016 - 06/10/2016 : COMP

    Committee for Orphan Medicinal Products (COMP): 4-6October 2016

    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.

  • 04/10/2016 - 06/10/2016 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 October 2016

    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.

  • 03/10/2016 - 03/10/2016 : EMA

    Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects

    This workshop aims to provide an overview of non-clinical data requirements for the authorisation of human medicinal products, how to address these during the medicinal product development, and detail the approaches for biological and advanced therapy medicinal products. A regulatory brief on the new PRIME scheme is also included in the programme.