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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

September 2015

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  • 30/09/2015 - 30/09/2015 : EMA

    European Medicines Agency workshop on extrapolation across age groups

    The primary rationale for extrapolation is to avoid unnecessary studies in the target population for ethical reasons, for efficiency, and to allocate resources to areas where studies are most needed. In situations where the feasibility of studies is restricted, extrapolation principles may be applied for rational interpretation of the limited evidence in the target population in the context of data from other sources. As per the published European Medicines Agency (EMA) concept paper on extrapolation of efficacy and safety in medicine development, EMA is developing a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. With the aim of developing the regulatory framework the Agency is holding an EMA experts workshop on 30 September. This workshop aims to bring together experts from the European medicines regulatory network. Registration by invitation only.

  • 28/09/2015 - 28/09/2015 :

    European Commission conference - 50 years of European Union Pharma legislation: achievements and future perspectives

    To mark the 50th anniversary of the adoption of the first European Union (EU) pharmaceutical legislation, the European Commission is organising a one-day conference that will take place in Brussels on 28 September. The conference will review past achievements but also focus on the present and future role of EU pharmaceutical legislation in protecting the health of people in Europe and in the world, and in advancing science and innovation. There are still many challenges ahead. Different stakeholders view these challenges from different perspectives. The conference aims to facilitate an open and stimulating exchange with representatives from national governments, European institutions, national competent authorities, industry, healthcare professionals, academia and patient groups towards a shared vision for the future. Registration open until 24 July 2015.

  • 28/09/2015 - 29/09/2015 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 28-29 September 2015

    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.

  • 25/09/2015 - 25/09/2015 : CAT

    Committee for Advanced Therapies (CAT) and the International Society for Cellular Therapy (ISCT) workshop: challenges and opportunities for a successful development and approval of advanced therapy medicinal products

    The workshop is co-organised by the European Medicines Agency's (EMA's) Commitee for Advanced Therapies (CAT) and the International Society for Cellular Therapy (ISCT) and will take place during the ISCT Europe 2015 regional meeting. During this workshop, CAT wants to reach out to advanced therapy medicinal products (ATMP) developers from academia, hospitals and industry with a programme aiming to provide insight of CAT's considerations and expectations on quality development and manufacturing issues, non-clinical testing and clinical development of ATMPs. The programme includes also a talk on the EMA/CAT support available to ATMP developers and will allow interacting directly with the regulators in an open forum discussion.

  • 21/09/2015 - 23/09/2015 : EMA

    EudraVigilance training on electronic reporting of individual case safety reports 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. Places limited.

  • 21/09/2015 - 24/09/2015 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 21-24 September 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.

  • 17/09/2015 - 18/09/2015 : CAT

    Committee for Advanced Therapies (CAT): 17-18 September 2015

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

  • 17/09/2015 - 17/09/2015 : EMA

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

    This is a joint meeting with representatives from patients’, consumers’ and healthcare professionals’ organisations. Participants will discuss the PCWP/HCPWP work programmes for 2016. They will be updated on a number of initiatives and ongoing activities including the need for collaboration in pharmacovigilance to ensure effective health protection and promotion, the new pharmacovigilance systems and services. Participants will be presented with the results of the survey to National Competent Authorities and the results from VISUALIZE research study (PROTECT project). Other topics including the progress of the PCWP/HCPWP topic groups, feedback from the scientific committees, patients' and consumers' and healthcare professionals' organisations projects and initiatives will also be presented. Registration by invitation only.

  • 16/09/2015 - 16/09/2015 : EMA

    European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: workshop on risk minimisation measures

    This is a workshop on risk minimisation measures with representatives from patients’, consumers’ and healthcare professionals’ organisations. An overview of the regulatory environment supporting the development of risk minimisation measures will be provided to participants; In addition, current practices/experience in the implementation and evaluation of the effectiveness of additional risk minimisation measures will be shared, using concrete examples. Participants will also discuss challenges and opportunities posed by the implementation and evaluation of risk minimisation measures in real life clinical practice. Registration by invitation only.

  • 09/09/2015 - 11/09/2015 : PDCO

    Paediatric Committee (PDCO): 9-11 September 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.

  • 08/09/2015 - 10/09/2015 : CVMP

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

  • 07/09/2015 - 10/09/2015 : PRAC

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

  • 01/09/2015 - 03/09/2015 : COMP

    Committee for Orphan Medicinal Products (COMP): 1-3 September 2015

    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.