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clinical trials directive

This page shows the latest clinical trials directive news and features for those working in and with pharma, biotech and healthcare.

ABPI says UK role as clinical trial hub threatened by Brexit

ABPI says UK role as clinical trial hub threatened by Brexit

Others have argued the UK would benefit from leaving the EU as it would free the country from compliance with the unpopular Clinical Trials Directive (CTD), which has been criticised for ... We know the old Clinical Trials Directive did not function

Latest news

  • Safeguarding European research Safeguarding European research

    application. Moreover, in contrast with the former Directive, the EU Clinical Trials Regulation will see the introduction of a streamlined application procedure via a single entry point, the EU portal. ... Industry supports the provisions related to

  • Brexit: Medical research and the EU referendum Brexit: Medical research and the EU referendum

    referendum could affect research in the UK" />. On 20 May, International Clinical Trials Day, we look at how the referendum could affect research in the UK.  . ... Many who would like to leave the EU cite the 2004 Clinical Trials Directive (CTD) as a

  • Pharma slammed by MPs for withholding trial data Pharma slammed by MPs for withholding trial data

    The panel concludes that information is routinely withheld from doctors and researchers on clinical trials and - tellingly - suggests that "none of the latest proposals from regulators or industry adequately addresses the ... The European Medicines

  • Leaked EFPIA memo reveals transparency strategy Leaked EFPIA memo reveals transparency strategy

    Agency's (EMA) plans to force companies to publish all clinical study reports for their drugs. ... But in reality, they are members of EFPIA, who have actively lobbied in the opposite direction, and supported InterMune and AbbVie in suing the EMA to

  • EMA commits to disclosure of data from trials EMA commits to disclosure of data from trials

    Seeks feedback on clinical trial data access policy. The European Medicines Agency (EMA) released a draft policy on access to clinical trial data as it tries to strike a balance between ... The shift to greater openness seems inevitable in the wake of

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Latest Intelligence

  • Brexit: Implications for the pharma industry Brexit: Implications for the pharma industry

    From patents to the EMA, data protection to clinical trials, there's a lot that should be a concern. ... Clinical trials. In the EU, clinical trials for medicinal products and medical devices are currently regulated pursuant to a number of EU Directives:

  • Can UK pharma rise to the post-Brexit challenge? Can UK pharma rise to the post-Brexit challenge?

    We are already seeing research collaborations halted. People. The UK pharmaceutical industry runs the risk of a ‘brain drain’ as clinical research opportunities in the UK diminish. ... data. 2.The Clinical Trials Directive is currently detailed and

  • Interview: Stephan Tanda, EuropaBio Interview: Stephan Tanda, EuropaBio

    He makes the point that traditional clinical trials are not suited to the development of modern personalised medicines, which have smaller target groups, drawing attention to the large numbers needed for ... Talking about the European Commission's (EC)

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