clinical trials

Public consultation on Declaration of Helsinki on medical research involving human subjects

A two-month public consultation (15 April to 15 June 2013) on the World Medical Association’s Declaration of Helsinki on medical research involving human subjects has been launched by the World Medical Association. A revised version of the Declaration is available on the WMA website. This consultation is of particular interest in the context of the ongoing revision of the Clinical Trials legislation. Please click here for detailed information on the consultation process The (...)

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Also about: Health professionals , Research , Health Inequalities , medical devices , vulnerable groups , women health

Clinical trials: Exploring the limits of transparency

Glenis Willmott MEP (S&D, UK) took the initiative to bring together experts to discuss the extent to which more transparency could be workable in non-commercial clinical trials. The debate, which took place in the European Parliament on 10 April, served to present the key arguments for and against increased transparency in the context of administrative and data reporting requirements for academic researchers and patient safety. EPHA’s Position on Clinical Trials urges political (...)

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Also about: Pharmaceuticals and Medicines , Health Rights and Patients , Health professionals , Research , Healthcare services , Transparency , Health Inequalities , public health , patient rights , pharmacovigilance , health system

[Special Summary] EU General Data Protection Regulation and Health Research

On 17 December 2012, the European Parliament’s Committee on Civil Liberties, Justice and Home Affairs (LIBE) released its draft report on the European Commission’s proposal for a regulation on the processing and free movement of personal data. The proposal and the amendments offered in the draft report have implications for a number of elements of health, inlcuding health research. This article takes a closer look at the potential effects of the new legislation for research (...)

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Also about: Research , health system , data protection

Ireland’s Presidency Health Priorities presented

Ireland, in collaboration with its TRIO partners - Lithuania and Greece - has made a commitment to use its resources to prioritise solid progress on a number of key legislative dossiers in health and calls on member states to work together, sharing ideas, information and best practice. The Irish Presidency Programme, whose cornerstone is progressing the legislative agenda, contains a series of health priorities: on 23 January 2013 the Irish Minister of Health, James Reilly, presented them (...)

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Also about: tobacco and smoking , Cross Border Healthcare Directive , eHealth , medical devices , public health programme

Revised EPHA position on clinical trials

EPHA has revised its position on clinical trials following the European Commission’s release of a legislative proposal for a regulation over the summer. While the key elements remain the same, the updated version emphasises the need for clinical trials to go ahead so that different population groups can benefit from life-saving treatments, while underlining that patient safety must remain at the centre of the process, and not compromised by less rigid assessment procedures. The (...)

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Also about: Ageing and Older People , Access to Medicines , Pharmaceuticals and Medicines , Health professionals , Research , Health Inequalities , public health , Innovation , health system , health economics , women health

Clinical Trials: European Commission revamps the EU rules

The European Commission has published its draft proposal to revise the Clinical Trial Directive. According to the European Commission, the main aim of the revised proposal is to simplify the rules for conducting clinical trials in Europe, while maintaining the highest standards of patient safety. Once adopted, the proposed Regulation will replace the 2001 ’Clinical Trials Directive’. The objective is to ensure that Clinical Trials rules are identical throughout the EU. The (...)

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Also about: Pharmaceuticals and Medicines , Research , Patient safety , patient rights , Innovation

The European Medicines Agency launches website on new European database of suspected adverse drug reaction

The European Medicines Agency (EMA) launched last May 31st the new European database of suspected adverse drug reaction reports website. The launch of this website is a positive first step in the implementation of the EudraVigilance access policy. The information carried on the site relates to approximately 650 medicines and active substances authorised through the centralised procedure. Within a year the EMA aims to additionally publish suspected side-effect reports for common drug (...)

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Also about: Pharmaceuticals and Medicines , Drugs and Substance Dependance , health literacy , patient rights , antibiotic , drug resistance , counterfeit , pharmacovigilance , EMA

’’Recognise contribution of intensive care’’, urges MEP Buşoi at European Parliament event

On 15 May 2012, EPHA co-organised an event in collaboration with our member the European Society of Intensive Care Medicine (ESICM) at the European Parliament. Cristian Buşoi MEP (ALDE, Romania) hosted and moderated a policy debate on the contribution of ’’intensivists’’ to better patient outcomes and health systems, tied to the launch of a two-day exhibition to promote the ESCIM’s LIFE-PRIORITY campaign. The overall aim of the policy debate, entitled (...)

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Also about: Health professionals , Research , Patient safety , public health , technology , medical devices , health threats , Directive 36 , health economics , Intensive Care Medicine

Event at the European Parliament: Improving patient outcomes through intensive care medicine - 15 May 2012

On 15 May 2012, EPHA member the European Society of Intensive Care Medicine is organising, in collaboration with EPHA, a policy debate at the European Parliament entitled ’’Improving patient outcomes through intensive care medicine’’ to mark the launch of a two-day exhibition in support of the LIFE-PRIORITY campaign. Attend the European Society of Intensive Care Medicine’s (ESICM) policy debate and find out more about one of the most expensive, (...)

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Also about: Health Rights and Patients , Health professionals , Healthcare services , health literacy , public health , accidents and injuries , health promotion , technology , medical devices , health threats , antibiotic , health system , Health-promoting environment , Intensive Care Medicine

EMA reflection paper discusses globalisation of clinical trials

The European Medicines Agency (EMA) has published the final reflection paper on ethical and good clinical practice aspects of clinical trials of medicinal products for human use. Conducted outside of the EU/EEA and submitted in marketing authorisation, it produced several applications to the EU regulatory authorities. Entering into force on 1 May 2012, the EMA reflection paper aims to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials (...)

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Also about: Access to Medicines , Pharmaceuticals and Medicines , Research , Patient safety , patient rights , Innovation , pharmacovigilance , EMA