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Actualité (Assurance qualité)

Les flux Santé-UE relatifs à l'actualité et aux événements sont générés automatiquement selon des critères établis par la Commission européenne. Ils peuvent contenir des erreurs de classification.

Regularisation of homeopathic medicine in Belgium»  homeopathyeurope.org

On 12 July 2013, the Belgian Council of Ministers decided that homeopathy is a medical act. Only medical doctors, dentists and midwives are entitled to practise homeopathy, dentists and midwives only[...]

Cardiovascular disease prevention guidelines in clinical practice, reviewed. »  escardio.org

Authors: Peovska I. The more evidence based care is delivered the greater the impact of prevention on cardiovascular events. Find here a comprehensive review of the latest European cardiovascular dis[...]

Certification Monthly Report»  edqm.eu

16 September 2013 Certification Monthly Report of Activities The last monthly activity report for the Certification of Substances Division (DCEP) is now available: August 2013 Certification Monthly R[...]

European added value assessment on the application of the principle of equal pay for men and women for equal work of equal value - Just Published - EU Bookshop»  europa.eu

European added value assessment on the application of the principle of equal pay for men and women for equal work of equal value[...]

EFSA Info Session on Applications – Workshop with Member States, applicants and stakeholders on EFSA Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees)»  europa.eu

Published on: EFSA held a workshop with pesticide specialists from Member States, industry and consumer groups to present, exchange points of view and clarify the main points of the Authority's Guida[...]

PRESS RELEASE: EFA reveals discrimination against patients requiring oxygen on board planes!»  efanet.org

Fancy going from Paris to Marseilles by plane? As an healthy passenger, you would pay 100 Euro. If you require oxygen on board the plane, the cost of the ticket can go up to 700 Euro! When you are a [...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2013»  europa.eu

The Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations on two medicines and started one new safety review at its September 2013 meeting.[...]

[EPHA Analysis] The 2013 (European Commission's) Country Specific Recommendations»  epha.org

On 29 May 2013, the European Commission published its proposals for the 2013 Country Specific Recommendations (CSRs) for the third annual cycle. In 2013 there are an increased number of CSRs on pover[...]

Revised guidance on applications for 'sister files'»  edqm.eu

03 September 2013 Certification - Revised guidance on applications for [...]

International consensus achieved on development, validation, nomenclature and quality control of multiple-loci variable-number tandem repeat analysis (MLVA) method for molecular typing of Salmonella Typhimurium: does it matter for public health? »  europa.eu

An international consensus study on standardisation of a widely developed molecular subtyping method for Salmonella Typhimurium, multiple loci variable-number tandem repeat analysis (MLVA), was publi[...]

Four new practice guidelines at ESC Congress 2013»  escardio.org

Just like the features of this wonderful city of Amsterdam, our Clinical Practice Guidelines share both the historical and the modern in a mix of expertise based on experience and respect for scienti[...]

Final Report Summary - MS COGNITIVE REHAB (Development and Evaluation of a Cognitive Rehabilitation Program for Persons with Multiple Sclerosis)»  europa.eumsw8

TEL AVIV UNIVERSITY Multiple sclerosis (MS) is a progressive neurological disease that affects over 400 000 people living in the European Union (EU). Approximately 50 % of persons living with MS will[...]

Periodic Report Summary - MS COGNITIVE REHAB (Development and evaluation of a cognitive rehabilitation programme for persons with multiple sclerosis)»  europa.eumsw8

TEL AVIV UNIVERSITY The goal of this study was to develop and test a cognitive rehabilitation programme designed for persons with multiple sclerosis (PwMS) through the following steps: - Step 1: Imme[...]

Periodic Report Summary - MEDEA (Models and their effects on development paths: an ethnographic and comparative approach to knowledge transmission and livelilhood strategies)»  europa.eumsw8

GOLDSMITHS' COLLEGE Project context and objectives: MEDEA is an interdisciplinary research project based on a historically sensitive and multi-scalar approach to development paths and their effects o[...]

The European Pharmacopoeia revises its strategy regarding implementation of chapter 5.20 "Metal catalysts or Metal reagent residues"»  edqm.eu

30 August 2013 The European Pharmacopoeia Commission revises its strategy regarding the implementation of Chapter 5.20 [...]

EAUN launches “Catheterisation: Urethral Intermittent in Adults” Guidelines»  uroweb.org

The EAUN has launched at the 14th International EAUN Annual Meeting held in Milan last March its fifth evidence-based guidelines, with urethral intermittent catheterisation and dilatation in adults a[...]

Guidance on the environmental risk assessment of genetically modified animals - Just Published - EU Bookshop»  europa.eu

Guidance on the environmental risk assessment of genetically modified animals[...]

New options for strengthening standards on social and environmental responsibilities of corporations and their implementation - Just Published - EU Bookshop»  europa.eu

New options for strengthening standards on social and environmental responsibilities of corporations and their implementation[...]

The European Pharmacopoeia (Ph. Eur.) Commission has adopted two new Biological Reference Preparation (BRP) »  edqm.eu

09 August 2013 The European Pharmacopoeia Commission adopts two new BRPs Pancreas powder (lipase) BRS Batch 4 (Y0001631) and Pancreas powder (amylase) BRP Batch 4 (Y0001632) The European Pharmacopoei[...]

Final Report Summary - PROSPER (Prostate cancer: profiling and evaluation of ncRNA)»  europa.eumsw8

TAMPEREEN YLIOPISTO Executive Summary: Annually, over 200 000 new prostate cancer cases are diagnosed in Europe. The widespread use of prostate specific antigen (PSA) tests on asymptomatic men and an[...]

Assessing the sustainability of aquaculture production»  europa.eu

Global consumption of seafood has risen dramatically over the last decade, due to a growing population, increased affluence and changing eating habits - many now see seafood as a healthy alternative [...]

European Medicines Agency and US Food and Drug Administration release first conclusions of parallel assessment of quality-by-design applications»  europa.eu

The European Medicines Agency (EMA) and the US Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessme[...]

New report assesses the added value of the EU Alcohol Strategy »  eurocare.org

DG SANCO has released the report that assesses the EU Alcohol Strategy.[...]

Guidance on integrating climate change and biodiversity into strategic environmental assessment - Just Published - EU Bookshop»  europa.eu

Guidance on integrating climate change and biodiversity into strategic environmental assessment[...]

Water footprint in the context of sustainability assessment - Just Published - EU Bookshop»  europa.eu

Report on the application of life cycle based indicators of water consumption in the context of integrated sustainability impact analysis[...]

Notice - Public Holidays»  edqm.eu

14 August 2013 Notice - Public Holidays Please note that the EDQM will be closed on Thursday, 15 August 2013. The office will reopen on Friday, 16 August. Information on public holidays[...]

Regulatory information - Revised dossier-submission requirements for active-substance master files»  europa.eu

The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file[...]

Middle East respiratory syndrome coronavirus neutralising serum antibodies in dromedary camels: a comparative serological study»  europa.eu

A study published in the Lancet Infectious Diseases on 9 August 2013 by Reusken et al identified antibodies to MERS-CoV in camels both in Oman and Spain. A total of 50 out of 50 (100%) sera sampled f[...]

Research Headlines - Losing sleep? Scientists evaluate why»  europa.eu

The issue of sleep deprivation has gone beyond the counting of sheep and into the scientific domain, as European researchers set up 'sleep labs' to study the biomedical and sociological factors keepi[...]

The Executive Agency for Health and Consumers launched 2 new calls for tender in the area of public health (europa.eu, ) »

2 new calls are related to good practices in the field of blood transfusion and Multiple Framework Contracts with reopening of competition to support tobacco policies[...]

Taking rejection out of organ transplant operations»

Organ transplant operations save lives. But for recipients, treatment does not end with an operation - they must take medication for the rest of their lives. The EU-funded project ONE Study is looking to change this through cell therapy - using cells themselves to stop a donor recipient's body from attacking the transplanted organ.

Regularisation of homeopathic medicine in Belgium»  homeopathyeurope.org

On 12 July 2013, the Belgian Council of Ministers decided that homeopathy is a medical act. Only medical doctors, dentists and midwives are entitled to practise homeopathy, dentists and midwives only[...]

New appointment announced at the EDQM»  edqm.eu

26 July 2013 New appointment announced at the EDQM The EDQM is pleased to announce the appointment of Dr Karl-Heinz Buchheit as Head of the Department Biological Standardisation, OMCL Network & H[...]

Regularisation of homeopathic medicine in Belgium»  homeopathyeurope.org

Sign up for the ECH newsletter and stay informed about homeopathy in Europe On 12 July 2013, the Belgian Council of Ministers decided that homeopathy is a medical act. Only medical doctors, dentists[...]

Information and consultation at work: Commission evaluates EU rules»  europa.eu

The European Commission has released the results of an evaluation to identify excessive burdens, overlaps, gaps or inconsistencies which may have appeared since the adoption of three EU Directives re[...]

Updated application forms available»  edqm.eu

25 July 2013 Updated application forms available The application forms for requests for certificates of suitability (CEPs) have been updated: - Changes to the declaration that the holder/intended hol[...]

EDQM “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs” and related documents revised»  edqm.eu

The EDQM has revised its guidelines to include the new requirements of the revised European guideline on variations to marketing authorisation applications. The structure of the document has also bee[...]

Events - NanoFATE project Open Day - Nano ecotoxicology and safety assessment - 25 September 2013, Wallingford, UK »  europa.eu

NanoFATE Coordinator Claus SVENDSEN (NERC-CEH, UK) invites you to attend our Open Day (preceded by a 2-day OPEN PhD WORKSHOP - ask us about it!) On Wednesday 25 September in Wallingford (near Oxford,[...]

Regulatory information - Revision of procedural guidance to reflect update of variations guidelines from the European Commission»  europa.eu

The European Medicines Agency has revised its procedural guidance for pharmaceutical companies to reflect the recent changes to the European Commission's guidelines on variations to the terms of mark[...]

EFSA consults on draft guidance for evaluating studies to measure pesticide degradation time in soil»  europa.eu

Published on: 25 July 2013 EFSA has launched a public consultation on draft guidance to carry out a highly specialised aspect of environmental exposure assessment for pesticides. The proposed methodo[...]

Get involved in Quality Action»  aidsactioneurope.org

Are you implementing an HIV prevention program in Europe targeting MSM, PWIDs, migrants or PLWH? Or does your organisation represent these key populations? Or are you an HIV policy maker? Quality Act[...]

Risk of further MERS-CoV cases in Europe remain: Rapid Risk Assessment on MERS-CoV updated»  europa.eu

The latest and sixth update of ECDC Rapid Risk Assessment on Middle East respiratory syndrome coronavirus (MERS-CoV)addresses the epidemiological situation since the previous Rapid Risk Assessment of[...]

Regulatory and procedural guideline: Qualification opinion of a novel data driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease, draft: consultation open»  europa.eu

On 20 March 2013 the Applicant Critical Path Global Ltd. requested qualification opinion for the proposed Disease Progression and Trial Evaluation Model.[...]

Scientific guideline: Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome, draft: consultation open»  europa.eu

This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of patients with Irritable Bowel Syndrome (IBS).[...]

Pharmacovigilance Risk Assessment Committee: one year of public health promotion and protection»  europa.eu

In a busy, exciting and productive first year establishing the new Pharmacovigilance Risk Assessment Committee (PRAC), the Committee has proactively grasped the opportunities of the new pharmacovigil[...]

Guideline on medicines for the treatment of irritable bowel syndrome released for a six-month public consultation»  europa.eu

The European Medicines Agency has released a draft guideline on the clinical investigation of medicines for the treatment of irritable bowel syndrome for a six-month public consultation.[...]

NEW BRP: Human Hepatitis B immunoglobulin BRP»  edqm.eu

18 July 2013 NEW BRP: Human Hepatitis B immunoglobulin BRP (Catalogue reference Y0001414) The European Pharmacopoeia Commission has adopted a new Biological Reference Preparation (BRP) for the assay [...]

Cumulative assessment group methodology – EFSA launches public consultation»  europa.eu

The European Food Safety Authority (EFSA) has launched a public consultation on its recently published methodology that identifies pesticides to be included in cumulative assessment groups. The appro[...]

NEW BRP: Hepatitis B immunoglobulin BRP»  edqm.eu

18 July 2013 NEW BRP: Hepatitis B immunoglobulin BRP (Catalogue reference Y0001414) The European Pharmacopoeia Commission has adopted a new Biological Reference Preparation (BRP) for the assay of Hep[...]

Heparin sodium BRP batch 3 for chromogenic assays»  edqm.eu

18 July 2013 Heparin sodium BRP batch 3 for chromogenic assays An international collaborative study coordinated by the EDQM for the Biological Standardisation Programme (BSP) has defined a new assign[...]

Public consultation on the guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another»  europa.eu

European Commission - 5 July 2013Public consultation on the guideline on the format and content of applications for designation as orphan medicinal products and on the transfer[...]

Evaluation of the implementation of the Strategy for Europe on Nutrition, Overweight and Obesity-related health issues»  epha.org

Launched in 2007, the Strategy for Europe on Nutrition, Overweight and Obesity-related health issues provides an integrated framework for action intended to contribute to reducing ill-health due to p[...]

Criteria for evaluating studies on stunning methods - EFSA consults on guidance document»  europa.eu

Published on: 15 July 2013 EFSA has launched a public consultation on a draft guidance on criteria to evaluate studies on the effectiveness of stunning methods. This document defines the assessment p[...]

Guide to the Preparation, Use and Quality Assurance of Blood Components»  edqm.eu

12 July 2013 Guide to the Preparation, Use and Quality Assurance of Blood Components 17th Edition (2013) The EDQM is happy to announce that the 17th Edition of the Guide to the Preparation, Use and Q[...]

The 8th Edition of the European Pharmacopoeia available soon»  edqm.eu

12 July 2013 The 8th Edition of the European Pharmacopoeia available soon Medicines are indispensable for ensuring patients' health and access to good-quality medicines and healthcare is a basic huma[...]

European Pharmacopoeia 8th Edition»  edqm.eu

12 July 2013 European Pharmacopoeia 8th Edition The 8th Edition will comprise a base volume 8.0 and eight non-cumulative supplements (8.1 to 8.8). The base volume will be published in July 2013 and t[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2013»  europa.eu

The Pharmacovigilance Risk Assessment Committee (PRAC) has marked the successful completion of its first year of operation.[...]

New publication from WHO - Health literacy. The solid facts»

As societies grow more complex and people are increasingly bombarded with health information and misinformation, health literacy becomes essential

EQA results show improvements in laboratory assessments of H. influenza and N. meningitidis»  europa.eu

Improvements have been recorded in two External Quality Assurance (EQA) tests, two new reports reveal. One test, covering Haemophilus influenzae, which was conducted in 2012, found several improveme[...]

Health System Performance Assessment (Belgium)»  europa.eu

Belgium piloted its first Health System Performance Assessment (HSPA) framework in 2008. The framework is a monitoring tool used to provide information to improve the basis for decision-making in hea[...]

Call for applications to join the Global Funds' Technical Review Panel»  aidsactioneurope.org

Members needed 2013 - 2016 The Technical Review Panel (TRP) is an independent group of international experts convened by the Global Fund to play an essential role in assessing funding requests receiv[...]

Use of rapid molecular assays for diagnosing tuberculosis and detecting drug resistance»  europa.eu

According to a new report, the use of rapid molecular assays has diagnostic value in tuberculosis (TB) identification and detection of drug resistance, although there is not enough evidence to recomm[...]

Scientific guideline: Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form, draft: consultation open»  europa.eu

This concept paper addresses the need to update and revise the CPMP/QWP/486/95 note for guidance on manufacture of the finished dosage form (1).[...]

Pharmacopoeial Discussion Group Achievements»  edqm.eu

03 July 2013 Pharmacopoeial Discussion Group Achievements 26-27 June 2013, Strasbourg (France) The meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Ph[...]

ENCePP guide on methodological standards in pharmacoepidemiology is revised»  europa.eu

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by the European Medicines Agency, has completed the second revision of the ENCePP guide on methodo[...]

Guidance for electronic and paper submissions »  edqm.eu

03 July 2013 Guidance for electronic and paper submissions The EDQM « Guidance for electronic and paper submissions for Certificates of Suitability (CEPs) applications » has been revised The EDQM has[...]

Falsified medicines directive: imported active substances need written confirmation to guarantee GMP standards»  europa.eu

From 2 July 2013, all active substances manufactured outside of the European Union (EU) and imported into the EU must be accompanied by a written confirmation from the competent authority of the expo[...]

Do you want to see EFSA’s risk assessment in action? Come and join our panel meetings!»  europa.eu

Published on: 2 July 2013 EFSA recognises that stakeholders want to better understand the risk assessment process. If advice and action in relation to food safety risks are to be trusted, it is cruci[...]

Lithuanian Presidency of the Council of the EU – Priorities in health sector»

Lithuanian Minister of Health Vytenis Povilas Andriukaitis has named the revision of the Tobacco Products Directive, concentration on sustainable heath systems, continuity of Ireland's efforts to reach general approach on clinical trials on medicinal products for human use and mediating the discussions on the Regulations on medical devices as well as on in vitro diagnostic medical devices as the priorities during the Lithuanian EU Council Presidency.

Scientific guideline: Draft note for guidance on clinical investigation of medicinal products for treatment of asthma, draft: consultation open»  europa.eu

This document is intended to provide guidance for the clinical evaluation of new medicinal products for the treatment of asthma.[...]

Scientific guideline: Draft guideline on adjustment for baseline covariates, draft: consultation open»  europa.eu

The note for guidance on statistical principles for clinical trials (ICH E9) briefly addresses the problem of adjustment for covariates. It advises experimenters `to identify the covariates expected [...]

Scientific guideline: Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, draft: consultation open»  europa.eu

The reflection paper (RP) should provide an overview of statistical principles with a potential of useful application in the context of the comparison of quality attributes as mentioned above. For si[...]

Brief interventions on alcohol and other drugs: improving health and the quality of health services provision (18-20.9.13) Rome»  eurocare.org

The European Alcohol Policy Alliance is a network of public health orgnisations working on alcohol policy, alcohol prevention and reduction of alcohol related harm in Europe through effective and evi[...]

Meat inspection: EFSA completes review of practices and recommends improvements»  europa.eu

EFSA is the EU risk assessment body for food and feed safety. It provides independent scientific advice to risk managers.[...]

PREFER AF shows European clinicians adhere well to AF guidelines / Issue III registry defines best syncope candidates for cardiac pacing»  escardio.org

The PREFER AF study2 found that Oral anticoagulation is now used in over 85% of patients with atrial fibrillation (AF) eligible for therapy. And ISSUE (the International Study on Syncope of Uncertain[...]

New Guidelines put cardiac pacing and resynchronisation in the real world»  escardio.org

The 2013 Guidelines, launched at EHRA EUROPACE, have been heralded as offering a much more accessible format for users than ever before. [...]

Guidance on submission of single assessment PSURs published»  europa.eu

The European Medicines Agency has given guidance to marketing authorisation holders on how to submit Periodic Safety Update Reports (PSURs) for medicines subject to EU single assessment via its esubm[...]

18th Annual Meeting of the OMCLs»  edqm.eu

21 June 2013 18th Annual Meeting of the OMCLs 10-14 June 2013, Helsinki (Finland) The European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe held its 18th An[...]

Medicines for children: more research, more availability and more information compared with 5 years ago»  europa.eu

European Commission Press release Brussels, 24 June 2013 Today, the Commission publishes a progress report on medicines for children covering the five years since the Paediatric Regulation came into [...]

AFib: What do the Guidelines currently say... and what should updates modify?»  escardio.org

Stroke prevention with appropriate thromboprophylaxis still remains central to the management of atrial fibrillation (AF). Thus, a crucial part of AF management requires the appropriate use of thromb[...]

Medicines for children - Major developments - First Commission Report on the Paediatric Regulation»

The Commission  has published a progress report on medicines for children covering the five years since the Paediatric Regulation first came into force. This preliminary snapshot points to improvements in the paediatric medicines landscape: better and safer research, more medicines for children on the EU market and more information for parents and health professionals.

Middle East respiratory syndrome coronavirus: updated guidance in ECDC Rapid Risk Assessment»  europa.eu

Latest on the Middle East respiratory syndrome coronavirus (MERS-CoV, previously the novel coronavirus), including travel guidance and aircraft contact tracing guidance in updated ECDC Rapid Risk As[...]

The eTACT service continues its progress»  edqm.eu

06 May 2013 The eTACT service continues its progress The eTACT project has taken further steps towards achieving a secure, patient-friendly and cost-effective traceability service for medicines. Thes[...]

EDQM participates in 23rd ISBT Congress»  edqm.eu

21 May 2013 EDQM participates in the 23rd Regional Congress of the ISBT The EDQM will participate in the upcoming 23rd Regional Congress of the International Society Blood Transfusion (ISBT) that wil[...]

Annual Meeting of the NPA of the European Pharmacopoeia»  edqm.eu

23 April 2013 Annual Meeting of the National Pharmacopoeia Authorities of the European Pharmacopoeia 15-16 April 2013 The annual meeting of the National Pharmacopoeia Authorities of European Pharmaco[...]

EDQM publishes Annual Report 2012»  edqm.eu

28 May 2013 EDQM Publishes Annual Report for the year 2012 The EDQM has published its 2012 Annual Report. The report outlines its different activities and provides an overview of achievements and res[...]

Coe initiative to improve BSM»  edqm.eu

28 May 2013 CoE questionnaire and method to assess and improve blood supply management (BSM) One of the decisions made by the group working on Blood Management Supply during the symposium held in Oct[...]

Launch of a new webpage for the 8th Edition»  edqm.eu

29 May 2013 Launch of a new webpage for the 8th Edition A new webpage has been created under the [...]

World Blood Donor Day: access to safe and high quality blood, a priority for Council of Europe’s healthcare policy»  edqm.eu

05 June 2013 World Blood Donor Day 2013 Access to safe and high quality blood, a priority for Council of Europe's healthcare policy On 14 June each year, countries around the world celebrate World Bl[...]

EDQM Laboratory receives ISO/IEC 17025:2005 Accreditation»  edqm.eu

17 June 2013 EDQM Laboratory receives ISO/IEC 17025:2005 Accreditation The EDQM is proud to announce that its laboratory has been officially accredited as ISO/IEC 17025:2005 compliant on 23 April 201[...]

EDQM Laboratory receives ISO/IEC 17025:2005 Accreditation»  edqm.eu

17 June 2013 EDQM Laboratory receives ISO/IEC 17025:2005 Accreditation The EDQM is proud to announce that its laboratory has been officially accredited as ISO/IEC 17025:2005 compliant on 23 April 201[...]

2013 ESH/ESC Guidelines for the management of arterial hypertension »  escardio.org

Landmark clinical Guidelines introduced at Europe's biggest blood pressure conference in Milan: Lifestyle factors, lack of awareness by both patients and physicians, hesitancy in initiating and inten[...]

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013»  europa.eu

The Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on four safety referrals at its June 2013 meeting.[...]

Joint Action on Improving Quality in HIV Prevention Successfully Kicked-Off»  aidsactioneurope.org

On June 5-6, 2013 the kick-off of the Joint Action on Improving Quality in HIV Prevention took place in Berlin. AIDS Action Europe is an associated partner in this initiative. Identify WHY AIDS Actio[...]

Food: Questions and Answers on new rules for specific groups of consumers»  europa.eu

European Commission MEMO Brussels, 11 June 2013 What does this Regulation change? The Regulation amends the legislation that applies to foods for particular nutritional uses ('dietetic foods'). For e[...]

New strengthened rules for food for infants, young children and food for specific medical purpose»  europa.eu

European Commission Press release Brussels, 11 June 2013 Today, the European Parliament gave its green light on a set of clearer rules protecting specific groups of consumers such as infants and youn[...]

Scientific guideline: Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, draft: consultation open»  europa.eu

This guideline lays down the non-clinical and clinical requirements for a biological medicinal product claiming to be similar to another one already marketed ([...]

Revised guideline on biosimilars containing biotechnology-derived proteins published for public consultation»  europa.eu

The European Medicines Agency has released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-de[...]

Regulatory and procedural guideline: Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure, draft: consultation open»  europa.eu

The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the cen[...]

Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module VI – Management and reporting of adverse reactions to medicinal products, draft: consultation open»  europa.eu

This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and Chapter 3 of Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in Me[...]

Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators, draft: consultation open»  europa.eu

Risk minimisation measures are public health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or[...]

Public consultation open on guideline on the acceptability of names for human medicines»  europa.eu

The European Medicines Agency has released the sixth revision of the guideline on the acceptability of names for human medicinal products processed through the centralised procedure for public consul[...]

Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders»  europa.eu

Marketing-authorisation holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the European Medicines Agency (EMA), in accordance with the [...]

Periodic Report Summary 2 - PAPA (Promoting Adolescent health through an intervention aimed at improving the quality of their participation in Physical Activity)»  europa.eumsw8

THE UNIVERSITY OF BIRMINGHAM Project context: The rise in childhood obesity is a global epidemic with immense consequences for public health (WHO, 2007). One key contributor to the increased prevalen[...]

New publication - Strategic intelligence monitor on personal health systems, phase 2 »

Citizens and ICT for health in 14 European countries : results from an online panel published in a new publication.

Revised version of application form for initial evaluation of human medicines available»  europa.eu

The European Commission has published a revised version of the application form for all marketing-authorisation applications for medicines for human use.[...]

Scientific guideline: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease, draft: consultation open»  europa.eu

Since the publication of the EMA Guidance on clinical investigation of medicinal products for the treatment of venous thromboembolic disease (CPMP/EWP/563/98) in 2000, there has been an intense resea[...]

Hepatitis A: EFSA and ECDC publish a joint rapid outbreak assessment»  europa.eu

Published on: 29 May 2013 EFSA is working closely with ECDC to help identify the origin of the recent outbreak of Hepatitis A virus infection in humans in Germany, the Netherlands and Poland. All 15 [...]

European Medicines Agency publishes guideline on clinical investigation of medicines for depression»  europa.eu

The European Medicines Agency has published a guideline on clinical investigation of medicines for the treatment of depression.[...]

Scientific guideline: Draft guideline on the clinical development of medicinal products intended for the treatment of pain, draft: consultation open»  europa.eu

This document is intended to give guidance on the investigation of medicinal products to be used in the treatment of nociceptive pain and / or of central and peripheral neuropathic pain.[...]

Joint ECDC-EFSA assessment: outbreak of hepatitis A virus infection in residents and travellers to Italy »  europa.eu

Since 1 January 2013, 15 laboratory-confirmed cases of hepatitis A have been reported in Germany, the Netherlands and Poland. All cases had travelled to northern Italy during the exposure period. 29/[...]