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More than 1,000 amendments will be discussed today (29 May) during the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) meeting on the proposals for a Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. An overview of key issues is provided below.
On 3 and 12 April 2013, the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) published two draft reports amending the (...)
13 May, Brussels -The motto of the 2013 eHealth week (13-15 May), which kicks off today, is ‘Delivering Innovative Healthcare and Well-being’. According to the European Commission, eHealth Week aims to encourage continuous investment in health IT in an effort to improve patient care and get a handle on rising medical costs.
An integral part of this year’s eHealth Week is the High Level eHealth Conference, organised by the Irish Presidency and the European Commission. (...)
As one of the deliverables of the pharmacovigilance legislation, that came into effect in July 2012, the European Medicines Agency (EMA) released an initial list of drugs subject to additional monitoring on 25 April 2013.
Please click here to read the full EMA Press Release, which contains additional information.
How to identify them?
Medicines subject to additional monitoring will have to display an inverted back triangle in their package leaflet and in the information for healthcare (...)
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
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 (...)
Pharmaceuticals and Medicines
Health Rights and Patients
Medical devices and in vitro diagnostic medical devices.
The term “medical device” covers an extremely diverse range of healthcare instruments – from simple bandages and dressings to tongue depressors, medical thermometers and blood sugar meters to pacemakers and life-supporting products, as well as eHealth devices which communicate remotely.
The medical devices industry constitutes a key sector for healthcare. It is one of the most dynamic sectors, improving and saving (...)
The third annual Flu Summit organised by EPHA member the European Scientific Working Group on Influenza will take place on 2 May 2013 in Brussels. It will be an opportunity to learn about and discuss with experts issues such as pandemic preparedness, new influenza target groups, and vaccination strategies.
This year’s edition focuses on new developments and challenges in the influenza field, with special attention for discussions on safety and effectiveness of influenza vaccines. (...)
Please find below information on the EPHA Working Group on Complementary and Alternative Medicine (CAM), which met for the first time in January 2013. All interested EPHA members are welcome to join the group regardless of whether or not they are actively working on CAM issues.
The Working Group on CAM falls under EPHA’s Strategic Aim 2 on Health Systems, which covers issues related to health professionals, health threats and communicable diseases, healthcare services / health (...)
The European Medicines Agency (EMA) organised a workshop on Medication Errors on 28 February – 1 March, a timely event given that such incidents are much more frequent across Europe than is commonly known. They are the most common preventable cause of adverse events in medication practice.
The workshop was opened by EMA Director Guido Rasi who stated that, although the reporting of suspected adverse drug reactions to the EMA-administered EudraVigilance database forms an integral part (...)
On 19 March 2013 a workshop on medical devices took place in the European Parliament to continue discussions over the legislative proposal presented by the European Commission in September 2012. The workshop was organised by the S&D Group (Group of the Progressive Alliance of Socialists and Democrats in the European Parliament) and was chaired by the Rapporteur for the Medical Devices report, Dagmar Roth-Behrendt MEP (Germany, S&D).
The discussion over the two proposals on Medical (...)