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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.

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

Latest news

  • 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

    In this digital roundup we look at the EMA's clinical trials portal, the chief digital officer role, Merck's popular periodic table app and more. ... The EMA will launch its new clinical trials portal and database in October 2017 as part of its

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

    MEPs agree clinical trial regulation revision. Paves way for EU trial database and simplified online applications for new studies. ... Industry trade organisation the European Federation of Pharmaceutical Industries and Associations (EFPIA) and its US

  • 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

  • EU Parliament panel backs updated clinical trials regulations EU Parliament panel backs updated clinical trials regulations

    The proposals introduce a series of new measures, including the creation of a public EU-wide database for all clinical trials of new medicines, with a single portal for clinical trial ... that the preliminary draft of the revisions to the Clinical Trials

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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

    Clinical trial regulation in Mexico. Regulatory improvements make Mexico an appealing destination for clinical trials outsourcing. ... Moreover, training for clinical trial personnel, eg managers and coordinators, is also improving.

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