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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.

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This month's events

June 2016

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  • 30/06/2016 - 30/06/2016 : EMA

    Workshop on single-arm trials in oncology

    Situations in which a medicine shows significant anti-cancer activity in an area where patients have no treatment option or where the conduct of standard trials with a comparative arm is difficult, such as in rare cancers or selected populations for example, will be considered. Workshop participants will discuss experience gained so far with marketing authorisations based on single-arm trials data, the strengths and weaknesses of different approaches, and opportunities from data sharing initiatives. They will also explore the views of various stakeholders groups and discuss the need for further regulatory guidance with the ultimate aim of optimising the development of new cancer treatments in these situations.

  • 22/06/2016 - 24/06/2016 : PDCO

    Paediatric Committee (PDCO): 22-24 June 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.

  • 21/06/2016 - 21/06/2016 : EMA

    EudraVigilance information day

    This information day provides a forum to update stakeholders about latest developments with regard to EudraVigilance in the context of the implementation of the pharmacovigilance legislation. It further aims to facilitate change management as part of the Agency’s pharmacovigilance programme and the planning of modifications to business processes by medicines regulatory authorities and pharmaceutical companies.

  • 20/06/2016 - 23/06/2016 : CHMP

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

  • 17/06/2016 - 17/06/2016 : EMA

    Follow up information session on the TransCelerate initiative

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

  • 16/06/2016 - 17/06/2016 : 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.

  • 16/06/2016 - 16/06/2016 : MB

    Management Board meeting: 16 June 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.

  • 16/06/2016 - 17/06/2016 : CAT

    Committee for Advanced Therapies (CAT): 16-17 June 2016

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

  • 15/06/2016 - 15/06/2016 : EMA

    European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting

    The EMA Human Scientific Committees' Working Party with Healthcare Professionals' Organisations (HCPWP) meeting marks the start of the 2016 -2019 mandate. The discussion will focus on the revision of the EMA framework of interaction with the healthcare professionals.

  • 15/06/2016 - 15/06/2016 : EMA

    Healthcare Professionals' Organisations Working Party (HCPWP) workshop with academia

    The European Union (EU) Medicines Agencies Network Strategy to 2020 calls for sound collaboration between the network and the academic world to ensure that innovative medicines can be optimally developed for the benefit of all European citizens. A strong partnership between regulators and academia is indispensable for a proactive process to support innovation and channel it into the continuous evolution of regulatory science. This workshop is the culmination of the consultation process to define a framework for collaboration based on robust foundations. The specific objectives of the workshop are to collectively review the status quo, present different perspectives and expectations, and discuss the main pillars of the framework.

  • 14/06/2016 - 14/06/2016 : EMA

    10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP)

    2016 marks the 10th anniversary of the European Medicines Agency’s (EMA) PCWP. A working group of patients' organisations was first created in 2003. Following endorsement of its framework of interaction by EMA’s Management Board, the working group was formalised into an official working party, the PCWP. Building on the importance of multi-stakeholder dialogue, the PCWP regularly holds its annual meetings jointly with the Healthcare Professionals’ Working Party. The PCWP is a unique platform for exchange and dialogue with patients and consumers on all issues related to medicines. The EMA is proud of the work of the PCWP and this anniversary meeting will be an opportunity to reflect on past successes and to plan for the future.

  • 14/06/2016 - 14/06/2016 : EMA

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

    This PCWP meeting welcomes the new members and representatives for the 2016 – 2019 mandate. Updates will be given on the EMA initiatives to support and accelerate early access: adaptive pathways and the PRIME initiative. Also to be discussed is the proactive publication of clinical study reports; the EUPATI guidance documents will be presented and feedback will be given from the scientific committees.

  • 14/06/2016 - 16/06/2016 : CVMP

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

  • 14/06/2016 - 16/06/2016 : COMP

    Committee for Orphan Medicinal Products (COMP): 14-16 June 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.

  • 13/06/2016 - 15/06/2016 : 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.

  • 13/06/2016 - 13/06/2016 : CVMP

    Veterinary focus group meeting with stakeholders: revision of the reflection paper on anthelmintic resistance

    The focus group meeting aims to facilitate the exchange of views from regulators, industry, research and veterinarians as part of the public consultation process on the revised draft reflection paper on anthelmintic resistance (CVMP/EWP/573536/2013-Rev.1). The Efficacy Working Party of the Committee for Medicinal Products for Veterinary Use (CVMP) revised the first version of the draft reflection paper to take into account comments received during public consultation. The CVMP adopted the revised reflection paper in April 2016 and released it for a second public consultation until 31 July 2016.

  • 07/06/2016 - 07/06/2016 : EMA

    Targeted consultation on the guideline for development of new medicinal products for the treatment of rheumatoid arthritis

    In the frame of public consultation on the revision of the guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis, the European Medicines Agency is hosting a meeting to supplement the ongoing debate.

  • 06/06/2016 - 09/06/2016 : PRAC

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

  • 02/06/2016 - 03/06/2016 : EMA

    2016 annual workshop of the European network of paediatric research (Enpr-EMA) at the European Medicines Agency

    The first day of the workshop is an open meeting to all stakeholders, including patient and parent organisations, network representatives, pharmaceutical industry staff responsible for paediatric studies and regulators. The main tocpics of the workshop this year will be the deliverables of the working groups and the implementation of the new Clinical Trial Regulation with a focus on ethics related issues. The second day is dedicated to members of Enpr-EMA and its coordinating group.

  • 01/06/2016 - 02/06/2016 : EMA

    IMI ADAPT SMART, IMI GetReal and MIT NEW Drug Development ParadIGmS (NEWDIGS) “Adaptive Design Laboratory” workshop

    The format of this two-day workshop is based on the NEWDIGS ‘scenario design’ methodology which leverages case studies to facilitate open yet structured discussion among stakeholders from different sectors regarding scientific, regulatory and utilization issues; and how potential options for integrated evidence generation and use plans across the product life span might help resolve those issues. In this workshop, Day 1 will focus on a retrospective case and, in particular, explore options for how Real World Evidence might be used to bridge the efficacy to effectiveness gap. Day 2 will be a retrospective review of a product, exploring “what if” Adaptive Pathways had been available, what other scenarios might have emerged in terms of its development, licensing, and utilization.