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The European Medicines Agency (EMA) publishes list of drugs under additional monitoring


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 (...)
25/04/2013

[Save the Date] Third Flu Summit of the European Scientific Working Group on Influenza (ESI)


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. (...)
30/03/2013

Broadband cuts threaten European Commission’s e-Inclusion goals


One of the European Commission’s key Digital Agenda for Europe goals, namely to provide access to fast broadband across Europe by 2013, is threatened by a decision by European heads of state to slash the budget. This could further impede working towards equity in the area of eHealth. Under its Digital Agenda for Europe strategy, which has also recently been relaunched with new targets, the Commission’s objective is for Europeans to have access to fast broadband by 2013 while (...)
01/03/2013

2013 PCWP/HCPs meetings at European Medicines Agency


EPHA is a member of the European Medicines Agency’s (EMA) Patients’ and Consumers’ Working Party and the Stakeholder Forum on Pharmacovigilance. Please find below information on the relevant meetings in 2013. Joint PCWP / HCPWP meeting 27-28 Feb 2013 Between 27-28 February, a joint Patients/Consumers Working Party and Healthcare Professionals Working Group meeting took place at the EMA in London. On day 1, the group discussed, among other things, the progress made in (...)
01/03/2013

[EPHA Statement] General Data Protection Regulation & Implications for Health Research


Data for health research must remain available for the benefit of society as a whole, whilst respecting the rights of the individual. 27 February, Brussels - The European Commission proposal for a regulation concerning data protection, released in January 2013, contains a number of exemptions and provisions crucial to facilitating vital health research within a framework of individual rights and protections. The public health community welcomed the proposal and its recognition of the (...)
27/02/2013

Chain of TRUST Closing Conference identifies key areas for improving trust and acceptability of telehealth


The ’’Chain of TRUST’’, a project to assess the perspective of the main end users of telehealth services across the EU, closing conference took place on 24 January 2013. The project examined the obstacles for the successful uptake of telehealth by their principal users, however the discussions went beyond the (still contested) notion of telehealth and provided useful food for thought on the wider challenges that the European eHealth sector is currently facing. (...)
04/02/2013

Fact or fiction? The Co-production of health and the digital user


In December, the 2012 EHTEL symposium explored, amongst other things, user perspectives in the domain of digital health. It was an opportunity to learn about new developments in eHealth and how they can help address health inequalities and improve access, particularly regarding less literate and disadvantaged population groups for whom the digital divide is still a reality. Following an introduction of the conference theme - ’’The Future of eHealth is already here’’ (...)
04/02/2013

Health Mediation Programme in Romania


This article provides information about a vital programme implemented by EPHA partner organisation SASTIPEN Roma Center for Health Policies, based in Romania. Their ’’Health Mediation Programme: Opportunity for increasing the employment rate amongst roman women” is an example of how economic and health objectives can be tackled simultaneously. Health Mediation Programme The health mediation programme represents the “business card” for Romania when discussing (...)
04/02/2013

How to prepare and review summaries of product characteristics (SmPCs)


On 21 January 2013 the European Medicines Agency (EMA) published on its website a guidance document for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. EMA’s guidance (as highlighted in their press release below) consists of a set of presentations detailing the information that should be included in each of the sections of the SmPC, together with background information on SmPCs both as a presentation and a video. (...)
04/02/2013

Council conclusions on Healthy Ageing across the Lifecycle


The December meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) adopted a set of conclusions on Healthy Ageing. It asks for a rethink of health systems towards more prevention. The Council also calls for a new Alcohol Strategy, to replace the current mandate which endsed in 2012. Europe’s population is rapidly ageing, which is challenging, among others, pillars of welfare , pensions, and healthcare systemss. The 2012 European Year for active ageing (...)
19/12/2012