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EMA publishes reflection paper
0Press Release:
EMA publishes reflection paper with guidance on assurance of ethical and GCP standards in the conduct of clinical trials included in marketing authorisation applications submitted in the EU.
The European Medicines Agency has published the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorisation applications to the EU regulatory authorities.
Entering into force on 1 May 2012, the aim of the paper is to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials meet the required ethical and GCP standards, no matter where in the world they have been conducted.
The reflection paper is part of the Agency’s strategy developed to address the challenges arising from the increasing globalisation of clinical research: no matter where you stand today, most clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in a different cultural setting. Yet regulators, healthcare professionals and patients worldwide all rely on the same trial data when making decisions on whether to allow a medicine on the market or not and on whether to use a medicine or
not.
The reflection paper has been endorsed by the Agency’s Committee for Medicinal Products for Human Use (CHMP), the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMD-h), the Agency’s Management Board and the Heads of EU Medicines Agencies, following an extensive public-consultation procedure....more
10 types of breast cancer
0New knowledge about cancer and its various sub types will change both diagnosis and treatment. Gender research about this prevelant form of cancer shows that this may consist of up to 10 different sub types. This new knownledge will improve the accuracy of diagnosis, care and treatment from the current situation which had identified only 4 sub groups. The study uses data form women who were diagnosed positive for cancer within the last 5-10 years…more
U.S. Churches vs Women’s Health?
0It appears several churches are or have now cut off aid to various organisations
Catholic Campaign for Human Development who give about $8 million to about 250 organisations in the U.S. annually has recently cut off aid to organisations that may be slightly connected to issues disagreeing with church teaching.
For example, it cut off thousands of dollars to a Colorado non profit providing health care and basic services to immigrants because they had joined an immigrant rights coalition who had joined forces with a statewide gay and lesbian advocacy group.
Recently, the United States Conference of Catholic Bishops issued a statement saying the Catholic Church should have a right to impose its values on fellow citizens “for the common good,” such as cutting off funds to groups with which the church disagrees.
Baptists too!
It seems that a Baptist organization is following suit with a health ministry in Georgia withdrawing grant funding to a women’s health clinic because of the services provided:
The Women of Worth clinic’s main goal is to provide Pap smears and cervical cancer screenings for women who cannot afford them — it does not provide abortions, said Executive Director Marilyn Ringstaff.
They has since received a letter from a vice president for the ministry, rescinding the grant offer.
Living longer and better!
0Event
Living longer, better, conference on EU reflection process on chronic diseases on 11 May 2012. Room 3C, Espace Borschette, 36 Rue Froissart, 1040 Brussels. From 10.00 to 16.00 including lunch break with sandwich lunch provided.
The stakeholders consultation on chronic diseases run by the European Commission raises questions and seeks recommendations from people and organisations concerned on issues of chronic diseases.
Conference objectives provide a unique opportunity to:
* Present recommendations on how to best prevent, treat and enhance research on Chronic Diseases
* Engage,debate and share ideas with others, peers, policy makers and media
* Make policy proposals supporting comprehensive approaches to Chronic Diseases.
REGISTRATION
Contact: event@copdcoalition.eu, tel: 02/741.24.75
Gender equality progress equals economic growth
0Progress in gender equality leads to economic growth, says EU report.
Improving equality between women and men is essential to the EU’s response to the current economic crisis, according to the European Commission’s latest annual report on gender equality. The report looks at progress over the past year in tackling the remaining gaps between women and men in employment, the economy and society in general. While some progress has been made in increasing the number of women in top jobs in business and in narrowing the gender pay gap, major challenges remain. EU countries need to get more women into the labour market if they are to meet the EU’s overall objective of 75% employment rate for all adults by 2020. One of the way’s of improving Europe’s competitiveness is to obtain better balance between women and men in economic decision-making positions. Studies have shown that gender diversity pays off and companies with higher percentages of women on corporate boards perform better than those with all-male boards.
“The economic case for getting more women into the workforce and more women into top jobs in the EU is overwhelming,” said Viviane Reding, Vice-President of the European Commission in charge of Justice, Fundamental Rights and Citizenship. “We can only reach our economic and employment goals by making full use of all our human resources – both in the labour market as a whole and at the top. This is an essential part of our economic recovery plans.”
Today’s report on progress made during 2011 on equality between women and men is part of the Commission’s broader report on the application of the EU Charter of Fundamental Rights in the past year (IP/12/370). It highlights the main developments at both national and European level across the five key areas in the EU’s overall gender equality strategy for 2010-2015, namely: the economy, equal pay, decision-making, gender-based violence and gender equality beyond the EU.
In the labour market, the employment rate for women is 62.1%, compared to 75.1% for men, meaning the EU can only reach the overall Europe 2020 target rate of 75% employment with a strong commitment to gender equality. Under the Europe 2020 strategy, the Commission has highlighted the need to promote a better work-life balance, in particular through adequate childcare, more access to flexible working arrangements, and by making sure tax and benefit systems do not penalise second earners (IP/11/685). These can all help to make sure more women enter and remain in the labour market.
The gender pay gap has narrowed slightly across the EU. On average, women earn 16.4% less than men for every hour worked. The gender pay gap is caused by multiple factors such as labour market segregation and differences in educational choices. The second European Equal Pay Day highlighted this issue and the potential solutions (IP/12/211). Slow progress in narrowing the gender gap in company boardrooms led the Commission to launch a public consultation on possible measures at EU level to address the problem, which risks holding back innovation and growth in Europe (IP/12/213).
Finally, the Commission took an important step towards the goal of ending gender-based violence by proposing a package of measures to strengthen the rights of crime victims (IP/11/585). This included a series of measures specifically aimed at helping women who fall victim to domestic violence.
Background
Promoting more equality in decision-making is one of the goals set out in the European Women’s Charter (see IP/10/237), which was initiated by President José Manuel Barroso and Vice-President Reding in March 2010. The Commission pursued these commitments by adopting a Gender Equality Strategy in September 2010 for the next five years (see IP/10/1149 and MEMO/10/430). The Strategy sets out a series of actions across four further areas in addition to equality in decision-making: equal economic independence; equal pay for work of equal value; dignity, integrity and ending gender-based violence; and gender equality in external policies.
A growing body of evidence points to significant economic benefits stemming from a better gender balance in economic decision-making. Having more women in top jobs can contribute to a more productive and innovative working environment and improved company performance overall. This bolsters competitiveness. Women account for 60% of new university graduates but few make it to the top of companies. Opening the door to senior positions acts as an incentive for women to enter and stay in the workforce, helping to raise female employment rates and making better use of women’s potential as human resources.
For more information: European Commission – DG Justice newsroom:
http://ec.europa.eu/justice/newsroom/index_en.htm
European Commission – Gender equality:
http://ec.europa.eu/justice/gender-equality
Video clip – gender pay gap:
http://ec.europa.eu/justice/gender-equality/gender-pay-gap
Homepage of Vice-President Viviane Reding, EU Justice Commissioner:
Zanzibar tackles gender violence
0The Zanzibar government is set to amend some of its laws to suit the current situation of fighting against gender-based violence in the isles.
It also plans to empower women economically and support private institutions and non-governmental organisations fighting against gender-based violence.
Speaking at the launch of a project on gender-based violence in Zanzibar on Thursday….more
Health funding face-off in Texas
0The 31 year old nursing student said she would have skipped the exam since she has no insurance, but she had just signed up for Texas’ Women’s Health Program, which provides cancer screenings, contraceptives and basic health care to about 130000 low-income women…more
International Women’s Day, 8th March 2012
0Press Release:
The European Institute of Women’s Health invites you to celebrate International Women’s Day and to promote the health of women throughout the EU. International Women’s Day is a time to reflect on progress made, to call for change and improvements to be made
Gender Equity in Health—Promoting Active and Healthy Ageing
Despite considerable progress in recent years at both national and international levels, gender inequalities in health remain in many areas across Europe. Strategies for promoting the health of women at the community level have not yet been introduced in any systematic way to the enlarged European Union. Neither has a systematic analysis been undertaken of how the healthcare sector could, or should, respond with greater sensitivity to the varying healthcare needs of women of all ages across all Member States…..more
EMA warnings for aliskiren-containing medicines
0European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines.
The European Medicines Agency finalised a review of aliskiren-containing medicines, recommending that these medicines should be contraindicated in patients with diabetes or moderate to severe renal impairment who take angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). In addition, the Agency recommended the inclusion of a warning that the combination of aliskiren and ACE inhibitor or ARB is not recommended in all other patients because adverse outcomes cannot be excluded. Doctors should stop prescribing aliskiren-containing medicines to patients with diabetes (type 1 or type 2) or with moderate to severe kidney impairment who are also taking an ACE inhibitor or ARB, and should consider alternative antihypertensive treatment as necessary.
For all other patients receiving aliskiren-containing medicines in combination with an ACE inhibitor or an ARB, the balance of benefits and risks of continuing treatment should be considered carefully. Patients should discuss their treatment with their doctor at their next scheduled (non-urgent) appointment. They should not stop any of their treatment before speaking to their doctor, because stopping anti-hypertensive medication without medical supervision can put them at risk. Patients in clinical trials with aliskiren should contact their study site for guidance on their medication.
For more information contact:
Fokion Sinis
Medical Information Sector
European Medicines Agency | 7 Westferry Circus | Canary Wharf | London E14 4HB | United Kingdom
Tel. +44 (0)20 7523 7432 | Fax +44 (0)20 7523 7129
fokion.sinis@ema.europa.eu | www.ema.europa.eu
20th International Conference on Health Promoting Hospitals
0EVENT
20th International Conference on Health Promoting Hospitals and Health Services (HPH)
11-13 April, 2012 Taipei, Taiwan
It will look back on what HPH originally set out to do, what the network has achieved so far, and what challenges and changes for the future lie ahead.
The Scientific Committee will highlight five major topics for the scientific program of the HPH conference 2012….more