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This section on health in the EU has been created as a trustworthy gateway to a wide range of information and data on health-related issues and activities at both European, national and international level. The content is produced by the European Commission, the Member States of the EU and the European Economic Area (EEA), plus EU candidate countries; by international organisations; and by pan-European non-governmental organisations in the area of public health.

[EPHA Analysis] Health in the 2014 Country Specific Recommendations    epha.org

17 July 2014 - On 2 June the European Commission published the 2014 round of Country Specific Recommendations (CSRs). This year, 15 member states have received recommendations related to health. Belo[...]

Scientific guideline: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non- surgical patients, draft: consultation open    europa.eu

A key element in the benefit risk assessment of drugs used for prophylaxis of venous thromboembolism (VTE) is balancing their antithrombotic effect versus the risk of bleeding[...]

Peer Review in Poland: The Active Ageing Index and its extension to the regional level    europa.eu

The Active Ageing Index (AAI) focuses on the untapped potential of older people, measuring their independence and participation in paid employment and social activities. In 2013, in a unique move, Po[...]

Peer Review in Slovenia: Long-term care – the problem of sustainable financing    europa.eu

Like most of Europe, Slovenia faces rapid population ageing. This places huge strain on long-term care (LTC) in particular, and the country has no unified system for providing it. To address this def[...]

Peer Review in Austria: The political adequacy of quantitative impact assessment in the social field by means of micro-simulation models    europa.eu

Since July 2013, the SORESI micro-simulation model has been helping Austria's policy-makers assess the likely impact of proposed policy reforms on the country's most vulnerable social groups. This Pe[...]

Peer Review in Belgium: Children First – pilot local consultation platforms on child poverty    europa.eu

In May 2014, the Belgian government embarked on funding a year-long pilot project of local `consultation platforms', intended to raise awareness of child poverty, provide parents with information abo[...]

Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies    europa.eu

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by the European Medicines Agency, has revised its guide on methodological standards in pharmacoepi[...]

Workshop on characterisation of new clotting factor concentrates: new report available    edqm.eu

11 July 2014 Workshop on characterisation of new clotting factor concentrates (FVIII, FIX): new report available A workshop on Characterisation of new clotting factor concentrates (FVIII, FIX) with r[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 July 2014    europa.eu

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety reviews and gave a recommendation as part of a regular benefit-risk assessment review of [...]

Pharmacopoeial Discussion Group achievements July 2014    edqm.eu

07 July 2014 Pharmacopoeial Discussion Group Achievements The meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and the United Stat[...]

Peer Review on Youth Guarantee, Helsinki, Finland, 18-19 September 2014    europa.eu

Over 30 delegates from different Member States and International bodies will attend a two-day Peer Review on the different experience and practices across EU countries regarding to specific aspects o[...]

Peer Review on Counterfactual Impact Evaluation, Prague, Czech Republic, 6-7 October 2014    europa.eu

Peer Review on counterfactual impact evaluation, Prague, Czech Republic, 6-7 October 2014[...]

Peer Review on Flexicurity, Copenhagen, Denmark, 13-14 November 2014    europa.eu

Peer Review on Flexicurity, Copenhagen, Denmark, 13-14 November 2014[...]

EDQM celebrates 50th Anniversary of the European Pharmacopoeia with inauguration of an exhibition    edqm.eu

02 July 2014 EDQM celebrates 50th Anniversary of the European Pharmacopoeia with inauguration of an exhibition To celebrate the 50th Anniversary of the adoption of the Convention on the elaboration o[...]

Committee of the PACE reassert total ban on any form of commercialisation of human organs    edqm.eu

01 July 2014 Committee of the PACE reassert total ban on any form of commercialisation of human organs On 24 June 2014, the Social Affairs Committee of the Parliamentary Assembly of the Council of Eu[...]

Scientific guideline: Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency, draft: consultation open    europa.eu

The aim of this guideline is to provide guidance on the clinical development of compounds used to prevent the development and to slow the progression of chronic renal insufficiency.[...]

Scientific guideline: Draft reflection paper on classification of advanced-therapy medicinal products, draft: consultation open    europa.eu

This reflection paper has been updated to reflect the current thinking of the Committee on Advanced Therapies (CAT) on substantial manipulation and non-homologous use. Additional changes have been im[...]

Scientific guideline: Questions and answers on benzalkonium chloride in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use, draft: consultation open    europa.eu

Following the European Commission decision to revise the annex of the guideline on excipients in the label and package leaflet of medicinal products for human use, a multidisciplinary group of expert[...]

149th Session of the European Pharmacopoeia Commission    edqm.eu

26 June 2014 149th Session of the European Pharmacopoeia Commission During its 149th session, the European Pharmacopoeia Commission adopted six new texts for inclusion in the European Pharmacopoeia, [...]

Scientific guideline: Concept paper on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and analyses, draft: consultation open    europa.eu

This Concept Paper proposes the drafting of a guideline on how to report the results from and performance of a Physiologically-based Pharmacokinetic (PBPK) analysis.[...]

Training to improve HIV Prevention in Europe    aidsactioneurope.org

Quality Action is a unique EU- wide project that aims to increase the effectiveness of HIV prevention in Europe. It promotes quality assurance (QA) and quality improvement (QI) tools that are adapted[...]

149th Session of the European Pharmacopoeia Commission    edqm.eu

26 June 2014 149th Session of the European Pharmacopoeia Commission During its 149th session, the European Pharmacopoeia Commission adopted six new texts for inclusion in the European Pharmacopoeia, [...]

TGA joins EDQM’s CEP assessment process    edqm.eu

26 June 2014 TGA joins EDQM's CEP assessment process The European Directorate for the Quality of Medicines and HealthCare (EDQM) and the Australian Therapeutic Goods Administration (TGA) are strength[...]

International scientific workshop: Risk assessment considerations for RNAi-based GM plants    europa.eu

Published on: More than 100 scientific experts attended EFSA's international workshop on RNAi (ribonucleic acid interference) in genetically modified (GM) plants in Brussels. The two-day event on 4-5[...]

EU project completes largest study of European building stock    europa.eu

The European Union is working towards ambitious targets for the reduction of energy consumption of buildings in Europe. This includes a bold renovation target which seeks to transform existing buildi[...]

Official medicines control laboratories : evolution of its role in Europe in surveillance and control of medicines on the market    edqm.eu

05 June 2014 Official medicines control laboratories : evolution of its role in Europe in surveillance and control of medicines on the market This year's Annual Meeting of the General European OMCL N[...]

Update to the European Pharmacopoeia Work Programme    edqm.eu

18 June 2014 Update to the European Pharmacopoeia Work Programme The work programme of the European Pharmacopoeia was recently updated (March 2014) with the texts to be revised, new texts to be elabo[...]

EDQM Published Annual Report for the year 2013    edqm.eu

18 June 2014 EDQM Publishes Annual Report for the year 2013 The EDQM has just published its 2013 Annual Report. The report is an opportunity to review the different activities of the past year and re[...]

Outcome report on first European collaboration between regulators and HTA organisations: improving the contribution of regulatory assessment reports to health technology assessment    europa.eu

The report of an initiative undertaken jointly by the European Medicines Agency (EMA) and the European network for Health Technology Assessment (EUnetHTA) to make regulators' reports about scientific[...]

Social entrepreneurship: new standard to measure social impact    europa.eu

European Commission Press release Brussels, 20 June 2014 A new standard to allow social enterprises of all sizes to better measure and demonstrate their social impact and so help them in their discus[...]

Social entrepreneurship: new standard to measure social impact    europa.eu

A new standard to allow social enterprises of all sizes to better measure and demonstrate their social impact and so help them in their discussions with partners, investors, and public sector funders[...]

Call for expressions of interest as Commission appointees to the European Commission Expert Group on Cancer Control    europa.eu

European Commission - Representative of producers of products or service providers in the field of cancer Representatives of pati[...]

EFSA assesses the risk from Salmonella and norovirus in berries    europa.eu

Published on: 18 June 2014 Rainfall, the use of contaminated water for irrigation or for applying pesticides, and contaminated equipment are among the factors that cause contamination of berries with[...]

EDQM Published Annual Report for the year 2013    edqm.eu

18 June 2014 EDQM Publishes Annual Report for the year 2013 The EDQM has just published its 2013 Annual Report. The report is an opportunity to review the different activities of the past year and re[...]

Update to the European Pharmacopoeia Work Programme    edqm.eu

18 June 2014 Update to the European Pharmacopoeia Work Programme The work programme of the European Pharmacopoeia was recently updated (March 2014) with the texts to be revised, new texts to be elabo[...]

Watch the HFA webinar on Iron deficiency in heart failure - From evidence to practice    escardio.org

Get an update with key opinion leaders on the impact of iron deficiency (ID) on CHF patients' outcomes and quality of life (QoL) independent of anaemia, and a review of newly released guidelines for [...]

Assessment of progress towards the Europe 2020 social inclusion objectives - Just Published - EU Bookshop    europa.eu

Main findings and suggestions on the way forward : short report[...]

Scientific guideline: Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies, draft: consultation open    europa.eu

The importance of the patient's point of view on their health status is fully acknowledged and such information may in principle be used in drawing regulatory conclusions regarding treatment effects.[...]

Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency    europa.eu

From today, the European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2014    europa.eu

At its June 2014 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (s[...]

Commissioner Andor welcomes adoption of new international standards to protect victims of forced labour and seafarers    europa.eu

László Andor, European Commissioner for Employment, Social Affairs and Inclusion has welcomed the adoption by the International Labour Organization (ILO) of two new international instruments to comba[...]

Labour protection: Commissioner Andor welcomes adoption of new international standards to protect victims of forced labour and seafarers    europa.eu

European Commission Press release Brussels, 11 June 2014 László Andor, European Commissioner for Employment, Social Affairs and Inclusion has welcomed the adoption by the International Labour Organiz[...]

MRL report: Diflubenzuron: Call for scientific data for use in CVMP assessment work of diflubenzuron and the review of the CVMP opinion for the establishment of maximum residue limits    europa.eu

Call for scientific data for use in CVMP assessment work of diflubenzuron: Review of the CVMP opinion for the establishment of maximum residue limits - Submission period: 10 June 2014 - 30 September [...]

Regulatory and procedural guideline: Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency, draft: consultation open    europa.eu

Scientific and medical literature is an important source of information on suspected adverse reaction case reports (also referred to as individual case safety reports). Currently, for active substanc[...]

Official medicines control laboratories : evolution of its role in Europe in surveillance and control of medicines on the market    edqm.eu

05 June 2014 Official medicines control laboratories : evolution of its role in Europe in surveillance and control of medicines on the market This year's Annual Meeting of the General European OMCL N[...]

Ranbaxy, Toansa assessment concluded: no risk to public health    europa.eu

European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at Ranbaxy Laboratories' manufacturing site in Toansa, India that had[...]

Dr Pascoal Mocumbi takes his leave as the EDCTP High Representative    edctp.org

With the end of the first programme nearing, Dr Pascoal Mocumbi has taken his leave as the High Representative of the European & Developing Countries Clinical Trials Partnership (EDCTP). Dr Mocum[...]

Dr Pascoal Mocumbi takes his leave as the EDCTP High Representative    edctp.org

With the end of the first programme nearing, Dr Pascoal Mocumbi has taken his leave as the High Representative of the European & Developing Countries Clinical Trials Partnership (EDCTP). Dr Mocum[...]

Commission decision establishing a Commission expert group on Cancer Control    europa.eu

Directorate General for Health & Consumers[...]

WBDD 2014    edqm.eu

04 June 2014 14 June: Join the EDQM (Council of Europe) to celebrate World Blood Donor Day (WBDD) Established in 2004, through the initiative of the World Health Organization (WHO), World Blood Donor[...]

Regulatory information – revised guideline on acceptability of names for human medicines is published    europa.eu

The European Medicines Agency has published a revised guideline on the acceptability of names for human medicines processed through the centralised procedure.[...]

Peer review on blended service delivery for jobseekers    europa.eu

The Dutch public employment service UWV WERKbedrijf will host this peer review from 5-6 June in Amsterdam, Netherlands. Representatives from the PES in Austria, Belgium (VDAB), Estonia, Finland, Fran[...]

Annual meeting of the National Pharmacopoeia authorities of the European Pharmacopoeia    edqm.eu

23 May 2014 Annual meeting of the National Pharmacopoeia Authorities of the European Pharmacopoeia (NPA) Twenty-three member States participated in this event. The NPA meeting provides a unique platf[...]

EDQM signs confidentiality agreement with TFDA    edqm.eu

26 May 2014 EDQM signs confidentiality agreement with TFDA The European Directorate for the Quality of Medicines & Healthcare (EDQM, Council of Europe), which celebrates its 50th anniversary in 2[...]

An environmental standards information portal for Europe    europa.eu

In Europe, we have a vast wealth of research results that support standards in relation to environmental aspects such as air, water, soil and waste. SIPE ('An environmental Standards Information Port[...]

Register now for UN Review & Assessment on NCDs    uicc.org

Global Education and Training Initiative Global Initiative for Cancer Registry Development Register now for UN Review & Assessment on NCDs Registration process for event on 10-11 July in New Yor[...]

Guide to the preparation, use and quality assurance of blood components – 17th Edition Now available in Macedonian    edqm.eu

28 May 2014 Guide to the preparation, use and quality assurance of blood components - 17th Edition Now available in Macedonian Guide to the preparation, use and quality assurance of blood components [...]

Scientific guideline: Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products and the related core summary of product characteristics, draft: consultation open    europa.eu

The currently approved `guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products' came into operation in January 2005. Since then, new fibrin sealant products h[...]

International workshop to explore risk assessment implications of emerging GM technique    europa.eu

Published on: 27 May 2014 EFSA is bringing together experts from across the globe to consider the implications for its risk assessment work from an emerging technique in the genetic modification of p[...]

Just published: Risk assessment of methoxetamine    europa.eu

This report presents the data and findings of the risk assessment on the new psychoactive substance, 2-(3-methoxyphenyl)-2-(ethylamino)cyclohexanone, that was conducted by the Scientific Committee of[...]

Just published: Risk assessment of 25I-NBOMe    europa.eu

This report presents the data and findings of the risk assessment on the new psychoactive substance, 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, that was conducted by the Scientific[...]

Just published: Risk assessment of MDPV    europa.eu

This report presents the data and findings of the risk assessment on the new psychoactive substance, 1-(1,3-benzodioxol-5-yl)-2-(pyrrolidin-1-yl)pentan-1-one, that was conducted by the Scientific Com[...]

Just published: Risk assessment of AH-7921    europa.eu

This report presents the data and findings of the risk assessment on the new psychoactive substance, 3,4-dichloro-N-{[1-(dimethylamino)cyclohexyl]methyl}benzamide, that was conducted by the Scientifi[...]

EDQM signs confidentiality agreement with TFDA    edqm.eu

26 May 2014 EDQM signs confidentiality agreement with TFDA The European Directorate for the Quality of Medicines & Healthcare (EDQM, Council of Europe), which celebrates its 50th anniversary in 2[...]

IARC/WHO & IACR launch cancer registry guidelines    uicc.org

Lyon, France, 26 May 2014 - The International Agency for Research on Cancer (IARC) , the World Health Organization (WHO) , and the International Association of Cancer Registries (IACR) today launch [...]

Annual meeting of the National Pharmacopoeia authorities of the European Pharmacopoeia    edqm.eu

23 May 2014 Annual meeting of the National Pharmacopoeia Authorities of the European Pharmacopoeia (NPA) Twenty-three member States participated in this event. The NPA meeting provides a unique platf[...]

Research Headlines - Reproducing plant-production processes for key drugs    europa.eu

Around one quarter of all prescribed pharmaceuticals in the developed world are derived from plants, including well-known drugs such as morphine and codeine. Harvesting plants to derive such medicine[...]

Public consultation: the evaluation of allergenic foods and food ingredients for labelling purposes    europa.eu

Published on: 23 May 2014 EFSA is inviting comments on its draft scientific opinion on the evaluation of allergenic foods and food ingredients for labelling purposes. The document updates previous EF[...]

List of texts adopted at the March 2014 session of the Pheur Commission    edqm.eu

21 May 2014 List of texts adopted at the March 2014 session of the Pheur Commission The new and revised texts will be published in Supplement 8.4 of the European Pharmacopoeia and implemented on 1 Ap[...]

Optimal outcomes require increased vigilance for HF co morbidities    escardio.org

Heart failure (HF), says Mitja Lainscak, should never be viewed in isolation, but considered together with other patient co morbidities. Topics: Heart Failure (HF)[...]

Iron deficiency predicts outcome in AHF    escardio.org

Iron deficiency (ID), defined as a combination of depleted body iron stores and unmet cellular iron requirements, identified acute heart failure (AHF) patients with the worst outcomes, reported a Pol[...]

A new Cancer Staging Tool is now available for free access    uicc.org

Global Initiative for Cancer Registry Development A new Cancer Staging Tool is now available for free access A collaboration of the Northern Ireland Cancer Registry (NICR) and the International Agen[...]

First draft finished product monograph with chemically defined active substance published for comment    edqm.eu

16 May 2014 First draft finished product monograph with chemically defined active substance published for comment Deadline for comments: 30 September 2014 In March 2014, the European Pharmacopoeia Co[...]

European guidelines on medical physics expert - Just Published - EU Bookshop    europa.eu

European guidelines on medical physics expert[...]

Use of a CEP for a starting material in an application for a CEP    edqm.eu

15 May 2014 Use of a CEP for a starting material in an application for a CEP A document is now available to provide clarification on the use of a CEP for a starting material in an application for a C[...]

Environment: Impact assessment of projects now simplified    europa.eu

European Commission Press release Brussels, 15 May 2014 New legislation simplifying the rules for assessing the potential effects of projects on the environment enters into force today. The newly ame[...]

Scientific guideline: Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis, draft: consultation open    europa.eu

The proposed guideline will replace the guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis (CPMP/EWP/422/04)[...]

Note from the Secretariat of The International Pharmacopoeia – Intended use of ICRS    edqm.eu

12 May 2014 Note from the Secretariat of The International Pharmacopoeia - Intended use of ICRS The International Pharmacopoeia constantly develops new monographs and revises existing ones to stay ab[...]

Office closure    edqm.eu

07 May 2014 Holiday Closure Dates The EDQM office will be closed on Thursday 8 May due to public holidays. It will reopen on Friday 9 May 2014.[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2014    europa.eu

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started two new safety reviews at its May meeting.[...]

Regulatory and procedural guideline: Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures, draft: consultation open    europa.eu

As the first step to market access, a new medicine requires a marketing authorisation from a medicines regulatory agency. The second step prior to enabling patient access to a new therapeutic option [...]

Dr Pascoal Mocumbi takes his leave as the EDCTP High Representative    edctp.org

With the end of the first programme nearing, Dr Pascoal Mocumbi has taken his leave as the High Representative of the European & Developing Countries Clinical Trials Partnership (EDCTP). Dr Mocum[...]

Medicines for Children - Responses to the public consultation on the Commission guideline on paediatric investigation plans    europa.eu

European Commission - Below are the public responses to the above-mentioned public consultation. A summary of the responses is here [...]

Scientific guideline: Draft concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus, draft: consultation open    europa.eu

Viral safety of plasma-derived medicinal products needs to be kept under review as viruses are identified that can be present in the plasma starting material. Initiating action with a workshop will p[...]

Scientific guideline: Draft guideline on non-clinical local tolerance testing of medicinal products, draft: consultation open    europa.eu

Local tolerance testing is intended to support human exposure to a medicinal product (both active substance and excipient) at contact sites of the body following clinical use.[...]

Scientific guideline: Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues, draft: consultation open    europa.eu

This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), claiming [...]

Scientific guideline: Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission, draft: consultation open    europa.eu

Guidance is provided on data requirements for process validation of biotechnology-derived proteins used as active substance in the manufacture of medicinal products. This guideline covers process eva[...]

Regulatory and procedural guideline: Draft European Union individual case safety report (ICSR) implementation guide, draft: consultation open    europa.eu

This guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electron[...]

Scientific guideline: Guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies, draft: consultation open    europa.eu

Guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies Guideline on the role of the pathological Complete Response as an endpoint in neoadjuv[...]

New publication: Handbook for inspection of ships and issuance of ship sanitation certificates    who.int

Disaster preparedness and response Haemophilus influenza (HiB) diseases Health 2020: the European policy for health and well-being Vector-borne and parasitic diseases The former Yugoslav Republic of[...]

EHC WorldHaemophiliaDay event showed that much remains to be done to achieve minimum standards of haemophilia treatment    edqm.eu

24 April 2014 EHC World Haemophilia Day event 16 April 2014, Wildbad Kreuth On 16 April, the European Haemophilia Consortium organised a meeting at the Paul-Ehrlich-Institute to present the EDQM reco[...]

EHC WorldHaemophiliaDay event showed that much remains to be done to achieve minimum standards of haemophilia treatment    edqm.eu

24 March 2014 EHC World Haemophilia Day event 16 April 2014, Wildbad Kreuth On 16 April, the European Haemophilia Consortium organised a meeting at the Paul-Ehrlich-Institute to present the EDQM reco[...]

Scientific guideline: Reflection paper on anthelmintic resistance, draft: consultation open    europa.eu

Helminth infections are common in most animals. Usually, a balance exists between helminths and the immune system of the animal and thus helminth infection will not lead to illness. However, in anima[...]

New publication: Eliminating measles and rubella. Framework for the verification process in the WHO European Region    who.int

Disaster preparedness and response Haemophilus influenza (HiB) diseases Health 2020: the European policy for health and well-being International Health Regulations Vector-borne and parasitic disease[...]

New publication: Eliminating measles and rubella. Framework for the verification process in the WHO European Region    who.int

Disaster preparedness and response Haemophilus influenza (HiB) diseases Health 2020: the European policy for health and well-being International Health Regulations Vector-borne and parasitic disease[...]

50th Anniversary International conference    edqm.eu

03 March 2014 50thAnniversary International conference On 6-8 October 2014, the EDQM is organising a landmark international conference to celebrate the 50th anniversary of the Convention on the Elabo[...]

Risk assessment vs risk management: What’s the difference?    europa.eu

Published on: 16 April 2014 The decision to separate the tasks of risk assessment and risk management just over a decade ago has transformed the safety of Europe's food. And while there is wide recog[...]

Call for scientific data for use in HMPC assessment work on Glycine max, lecithin, draft: consultation open    europa.eu

The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients' associations, governmental institutio[...]

Stop-the-clock guidelines to improve efficiency and consistency of regulated product assessments    europa.eu

Published on: 14 April 2014 New working practices will increase the efficiency, clarity and consistency of the assessment of regulated product applications, said the European Food Safety Authority (E[...]

Guidelines debate in favour of BCG maintenance    uroweb.org

Audience participation was an integral part of the Guidelines-dedicated Thematic Session 3 where the outcomes of pro and contra debates were revealed through voting. During the session Profs. Richard[...]

Hepatitis A: EFSA and ECDC update their rapid outbreak assessment    europa.eu

Published on: 11 April 2014 More than 1,300 hepatitis A cases have been reported in eleven Member States since January 2013, with 240 confirmed cases related to the ongoing outbreak. Initially the ou[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2014    europa.eu

The Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review and started four new safety reviews at its April meeting.[...]

Specifications for additional efficacy studies for medicines published in the Official Journal of the EU    europa.eu

The European Commission has adopted a delegated act specifying the situations where a post-authorisation efficacy study can be required by medicines regulatory authorities.[...]

Development and evolution of risk assessment for food allergens    eufic.org

The risk from the unintentional presence of an allergen in a food product must be assessed before it can be managed effectively. Using probabilistic modelling, the risk can be assessed by combining d[...]

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