Theorem Clinical Research

Europe

EMA’s clinical trial data policy delayed until October

Thursday, July 10, 2014 12:53 PM

The management board of the EMA has postponed formal adoption of the policy on publication of clinical trial data until its Oct. 2 meeting. Further clarifications on wording and practical arrangements will be discussed by board members, who have confirmed their general support of the overall aim and objectives of the policy, including the more user-friendly amendments proposed by Guido Rasi, EMA executive director, that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.

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Prescriptions in England up 60%, but costs up only 15% since 2003

Wednesday, July 9, 2014 12:10 PM

The number of prescription items dispensed in England has increased by 58.5% since 2003, according to a new Health and Social Care Information Center (HSCIC) analysis. Over 1.03 billion items were prescribed in 2013, compared to 649.7 million in 2003.

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EFPIA launches IMI2—a $4.5B public-private healthcare partnership

Wednesday, July 9, 2014 12:09 PM

EFPIA has announced the launch of IMI2, the continuation of the successful partnership of industry and public bodies to tackle health needs. IMI is a public-private partnership (PPP) between the European Commission and EFPIA, the European Federation of Pharmaceutical Industries and Associations. The first phase of IMI (2008 to 2013) was established with a budget of $2.7 billion. IMI2 has been established under the E.U. framework program Horizon 2020 with an even bigger budget of $4.5 billion—bringing together the public and private sectors in the largest healthcare PPP in Europe.

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U.K. Prime Minister commissions independent antibiotics review

Wednesday, July 2, 2014 12:48 PM

U.K. Prime Minister David Cameron, along with the U.K. Department of Health, has commissioned a wide reaching independent review, led by economist Jim O’Neill and co-funded and hosted by medical research foundation the Wellcome Trust, to explore the economic issues surrounding antimicrobial resistance. Growing numbers of bacterial and viral infections are resistant to antimicrobial drugs, but no new classes of antibiotics have come on the market for more than 25 years.

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ACRP, European Center for Clinical Research Training collaborate

Thursday, June 19, 2014 01:45 PM

The Association of Clinical Research Professionals (ACRP) and the European Center for Clinical Research Training (ECCRT), a SynteractHCR company, have introduced the ECCRT/ACRP STAR Program, a comprehensive and collaborative clinical research training and development program being offered across Europe.

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Medical Research Council launches U.K. Dementias Research Platform

Thursday, June 19, 2014 01:39 PM

The Medical Research Council (MRC) has launched the U.K. Dementias Research Platform (UKDP), a $27.2 million public-private partnership set up to speed up research into dementias. The collaboration aims to enable earlier detection, improved treatment and, ultimately, prevention of the disease by looking not just at what is going wrong in the brain, but at the brain in the context of the whole body.

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ESMO welcomes the adoption of the Clinical Trials Regulation by the E.U.

Tuesday, June 17, 2014 11:06 AM

The European Society for Medical Oncology (ESMO) has welcomed the adoption of the Clinical Trials Regulation by the E.U.

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Novo Nordisk to add 6,000 new jobs in Denmark by 2022

Friday, June 13, 2014 01:10 PM

Global healthcare company Novo Nordisk expects to hire 6,000 new employees in Denmark through 2022, half of whom will work within R&D. According to a Novo Nordisk report, the new jobs will have the derived effect of boosting employment by more than 15,000 jobs nationally.

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EMA responds to concerns on its publication of clinical trial data policy

Thursday, June 12, 2014 01:36 PM

The EMA Management Board meeting will consider a draft policy on the publication of clinical trial data. The draft policy arises from the agency’s commitment to increase access to clinical trial data and has been shaped by the many comments received during the consultation phase.

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EFPIA calls for universal adherence to European regulatory framework

Wednesday, June 11, 2014 12:51 PM

EFPIA, the European Federation of Pharmaceutical Industries and Associations, is concerned about a decision by the Italian health authority to allow the reimbursement of off-label treatments for economic reasons when on-label alternatives are available. The organization calls on the European Commission to ensure member states adhere to the European regulatory framework and that financial considerations do not take precedence over regulatory decisions. 

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September 29

WCG sees ePharmaSolutions’ clinical trial portal as the next step in the data evolution, company mission

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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