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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

November 2014

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  • 26/11/2014 - 26/11/2014 : EMA

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

    This is a meeting with representatives of the PCWP and all eligible patient and consumer organisations. Topics for discussion are involvement of patients and consumers in the Agency's activities, involvement of patient representatives in Agency committees, reporting of adverse drug reactions, feedback on the risk-management-plan (RMP) summary pilot, feedback from the International Society for Pharmacoepidemiology (ISPE) conference, the ADVANCE project on vaccines and a survey on collaboration at national level. Registration by invitation only.

  • 25/11/2014 - 25/11/2014 : EMA

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

    This is a training session for patients' and consumers' organisations involved in European Medicines Agency activites. Topics to be presented include an overview of the Agency and the centralised procedure, as well as how patients are involved in scientific advice, scientific-advisory-group (SAG) meetings, the review of information to patients and pharmacovigilance. Registration by invitation only.

  • 24/11/2014 - 25/11/2014 : EMA

    European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease

    The Agency is organising this workshop following the public-consultation exercise on its concept paper on the need for revision of the guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias. The aim of the workshop is to make sure that, while revising its guideline, the EMA can take the most up-to-date scientific developments in understanding and treating Alzheimer’s disease into consideration, as well as the positions of experts in the field. Registration is open until 01/07/2014. Places limited.

  • 24/11/2014 - 25/11/2014 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 24-25 November 2014

    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.

  • 21/11/2014 - 21/11/2014 : EMA

    European Union clinical trials portal and Union database: meeting with stakeholders

    In the new European Union (EU) Regulation on clinical trials, the Agency has been made responsible for developing and maintaining the IT platforms that will support sponsors and EU Member State representatives carry out their respective roles related to the submission, assessment and supervision of clinical trials in the EU. The EU clinical trials portal and Union database meetings with stakeholders will be held on various dates to inform the design and development of the systems. Registration by invitation only.

  • 20/11/2014 - 21/11/2014 : EMA

    eXtended EudraVigilance Medicinal Product Dictionary training course

    The training focuses on explaining the guidance, 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 also known as EVWEB. Places limited.

  • 20/11/2014 - 20/11/2014 : EMA

    The annual European Medicines Agency review of the year and outlook for 2015

    The 9th annual review of the activities of the European Medicines Agency (EMA) and the national agencies that work within the European regulatory system, and a look at the upcoming year, will take place in the EMA’s new offices at Canary Wharf. This key year-end conference is a firm favourite with European regulatory professionals as a chance to reflect and plan for the challenges ahead, as it: addresses all the major areas of medicines legislation coordinated by the EMA; provides practical advice on the workings of EMA within the European regulatory network and how the national agencies contribute; and includes a wide range of speakers and panellists from senior agency personnel to EMA senior leadership, patient organisation representatives, industry leaders, pan-European policymakers and consultants.

  • 18/11/2014 - 19/11/2014 : EMA

    Plasma master file epidemiology

    The purpose of this workshop is to look at data submission and evaluation and discuss the following topics: approaches to monitor trends and to establish acceptable ranges for epidemiological data, residual risk calculation, HBsAg adjustment factor and window periods used in calculations; extension of the trend analysis period to more than 3 years now that data is available over longer periods in the format required by the guideline; the usefulness of both graphical representations of trends and statistical significance approaches for trend analysis for organisations and countries; approaches to identify trends on a centre basis; criteria for acceptance of new centres in terms of epidemiological data. Registration by invitation only. Places limited. Registration open until 18/10/2014.

  • 17/11/2014 - 20/11/2014 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 17-20 November 2014

    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.

  • 17/11/2014 - 21/11/2014 : EMA

    European Commission - European Medicines Agency - China Food and Drugs Administration bilateral and International Summit of Heads of Medicines Regulatory Agencies

    The European Union China Working Group on Pharmaceuticals, which brings together the European Medicines Agency (EMA), the European Commission (EC) and the China Food and Drugs Administration, meets on 18 November to progress discussions on active-pharmaceutical-ingredient, good-clinical-practice and good-pharmacovigilance-practice inspection-related topics. The ninth International Summit of Heads of Medicines Regulatory Agencies takes place on 19-21 November, with representatives from EMA, EC, and a number of European, national and international partner regulators, including the World Health Organization. Discussions include registration of generics, biosimilars, access to medicines, innovative products and major public health concerns such as Ebola, antimicrobial resistance and dementia. The International Coalition of Medicines Regulatory Authorities meets on 20 November to review cooperation in good-manufacturing-practice inspection, information-sharing and capacity-building.

  • 17/11/2014 - 19/11/2014 : EMA

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

    Participants who pass the knowledge evaluation following the course will receive a notification from the European Medicines Agency (EMA) that will allow them to register with the EudraVigilance and report ICSRs to the EMA and / or the National Authorities in the European Economic Area. Places limited.

  • 14/11/2014 - 17/11/2014 : EMA

    Mutual reliance between the United States Food and Drug Administration and the European Union on good-manufacturing-practice inspections

    On 14 and 17 November 2014, representatives of the United States Food and Drug Administration (FDA) are meeting with a cross-agency team from the European Medicines Agency (EMA), the European Commission and good-manufacturing-practice (GMP) experts from European Union (EU) Member States in order to make progress on mutual reliance between the FDA and EU on GMP inspections. Initiatives have been ongoing in this field for several years but there is now renewed momentum on this issue. Representatives of both teams have met several times in recent months, answered questions and exchanged information. This meeting is the first face-to-face meeting of both complete teams specifically organised on this topic. It is intended to clarify and align aspirations and goals, detailed scope and timelines as well as to continue the exchange of information, clarification and discussion on respective systems for supervision of manufacturers.

  • 13/11/2014 - 14/11/2014 : CAT

    Committee for Advanced Therapies (CAT): 13-14 November 2014

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

  • 12/11/2014 - 14/11/2014 : PDCO

    Paediatric Committee (PDCO): 12-14 November 2014

    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.

  • 11/11/2014 - 13/11/2014 : COMP

    Committee for Orphan Medicinal Products (COMP): 11-13 November 2014

    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.

  • 07/11/2014 - 07/11/2014 : EMA

    European Medicines Agency workshop on the investigation of subgroups in confirmatory clinical trials

    The European Medicines Agency (EMA) is hosting a one-day workshop on the investigation of subgroups in confirmatory clinical trials. The workshop will follow a 6-month public consultation on the draft EMA guideline. Objectives of the workshop are to discuss the role of subgroup analyses in the assessment of confirmatory clinical trials submitted for marketing authorisation, and to receive input on positions outlined in the guideline.

  • 04/11/2014 - 06/11/2014 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 November 2014

    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.

  • 03/11/2014 - 06/11/2014 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 November 2014

    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.