Pharmaceutical News and Updates
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Simplified filing and review of studies in Austria
By Simon Ruini, London The Ethics Committee of the Medical University of Vienna has approved a new submission method of clinical research projects and also their assessment is now available online. Unlike in the past,…
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European Medicines Agency releases good pharmacovigilance practice modules for public consultation
The European Medicines Agency has released the first batch of modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012. Each of the seven modules released today covers one major process in…
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EU publishes new drafts of patient information and pharmacovigilance proposals
The European Commission has published the revised proposals on pharmacovigilance and information to patients, following its decision on 2 December last year to separate the two. The two proposals, which each take the form of…
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Disclosure by drug companies of results of clinical trials not necessary when they don’t lead to product development or commercialisation, but maybe useful for all parties involved.
Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research – even when product development is no longer being…
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Critics raise concerns over research, incentives of European pediatric exclusivity regulations
By Karyn Korieth Regulations introduced four years ago in Europe to encourage research into medicines for children have lead to important therapeutic breakthroughs for pediatric patients. Yet concerns also have been raised about how well…
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ENCePP publishes the ‘guide on methodological standards in pharmacoepidemiology’
The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published the ENCePP guide on methodological standards in pharmacoepidemiology, an important tool that reviews and gives direct electronic access…
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The EU executive is planning a major overhaul of the rules governing medical research amid a growing acceptance that a directive in place since 2004 has hampered clinical trials
The European Commission says it accepts that the implementation of the directive has been deeply flawed and will legislate to fix the problems by October 2011. The Commission’s health directorate – which was handed control…
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Innovation is in for EU’s Healthcare SystemEurope aim to increase jobs and growth through its “Europe 2020” strategy
By Peter O’Donnell It will come as little consolation to those already struggling to keep up with change to learn that more change is already on the way. Innovation is in, in Europe—again. And not…
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European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation
European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation On 15 April 2011, the European Medicines Agency held a stakeholder forum on the implementation of the new pharmacovigilance legislation…
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Should Doctors Shoulder Healthcare Costs?
By Jennifer Ringler As the debate over the rising costs of new drug R&D and brand name medications rages on, physicians are increasingly doing their part to minimize collateral damage inflicted upon the patient. A…