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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.

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

Latest news

  • 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

  • MEPs agree clinical trial regulation revision MEPs agree clinical trial regulation revision

    European Federation of Pharmaceutical Industries and Associations (EFPIA) and its US counterpart made various commitments to boost clinical trial transparency in July, and was measured in its response to the regulation, ... Increasing the timeline to

  • Modern values in healthcare Modern values in healthcare

    Such evolutionary lags are not unusual. The industry faced similar issues in the 1960s and 1990s, when first regulation and then clinical trial harmonisation represented significant changes and challenges to how ... In particular, it specifies the value

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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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