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clinical trial regulation

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

Signant Health joins the Association of Clinical Research Organizations

Signant Health joins the Association of Clinical Research Organizations

ACRO’s work has influenced some of the more recent clinical trial regulations such as the 21. ... st. Century Cures Act and EU Clinical Trial Regulation. Signant Health is the 13.

Latest news

  • Pharma’s confidence in Brexit deal falls as vote looms Pharma’s confidence in Brexit deal falls as vote looms

    supply of non-clinical consumables, goods and services; workforce; reciprocal healthcare; research and clinical trials; and data sharing, processing and access. ... registered in the UK will continue to be registered after Brexit, and a pledge to align

  • Clinical trial ‘High Throughput Centres’ could help UK compete post-Brexit Clinical trial ‘High Throughput Centres’ could help UK compete post-Brexit

    This sizeable share of the market will be put at risk by exiting the EU, which is likely to see the UK no longer part of EU clinical trial regulations, though ... A new online EU clinical trial portal will allow sponsors of trials involving multiple

  • Safeguarding European research Safeguarding European research

    One of the major aims of the Regulation has been to streamline the clinical trial application and supervision process - enabling research and underpinning the EU as a have for clinical trials ... EFPIA members have made significant progress in developing

  • The new EU clinical trial lay summaries The new EU clinical trial lay summaries

    Increasing patient and general public awareness and confidence about the clinical trial process. ... Trial summaries. The new Clinical Trial Regulation (EU No 536/2014) 5 comes into effect 'no earlier than May 2016'.

  • Digital roundup Digital roundup

    Genzyme, Merck, the forthcoming EU clinical trials portal and more. In this digital roundup we look at the EMA's clinical trials portal, the chief digital officer role, Merck's popular ... The EMA will launch its new clinical trials portal and database

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  • Unravelling China’s healthcare sector Unravelling China’s healthcare sector

    Domestic industry. In the last few years, not only the coverage of health insurance received its boost in China, the pharmaceutical regulatory framework, from API manufacturing to clinical trial regulation, has ... Jiangsu Hengrui Pharma and Hutchison

  • Clinical trial regulation in Mexico Clinical trial regulation in Mexico

    The total approval and set-up process for a clinical trial takes on average 3-4 months. ... Moreover, training for clinical trial personnel, eg managers and coordinators, is also improving.

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