News from the World of Clinical Research

Recent News

    EFGCP Workshop - Quality and Innovation in Complex Studies - 12th June London

    By James C / 5/29/2017 9:44:52 AM

    Join this exciting workshop organised by EFGCP, in UCL's Cruciform Lecture Theatre on Gower Street. Discussions range from how to prepare sites for complex studies; gene profiling in oncology; MHRA ex…

    UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

    By ICR Secretariat / 5/10/2017 12:07:20 PM

    At last weeks Forum on UK Pharmacovigilance Post-Brexit, a lot of hypotheticals were discussed, but little was said to calm the fears of Qualified People Responsible for Pharmacovigilance. Currently, …

    MHRA Formulating Post-Brexit Plan

    By ICR Secretariat / 5/10/2017 11:48:04 AM

    The MHRA have outlined their priorities for 2017/2018, including formulating a vision for the agencies post-Brexit future. One of its top priorities is to devise a five-year plan encompassing national…

    CDRH Forwards Alternate Path for Device Approvals

    By ICR Secretariat / 5/10/2017 11:09:55 AM

    The FDA's Centre for Devices and Radiological Health have presented a new path to 'Progressive' approvals for Medical Devices. This would allow devices already registered in Europe to be bought to mar…

    FDA, NIH & Industry Advance Templates for Clinical Trial Protocols

    By ICR Secretariat / 5/9/2017 2:12:31 PM

    The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) on Tuesday released the final version of a common template for clinical trial protocols intended to save sponsors of N…

    EMA Publishes Brexit Guidance Section of Their Website

    By ICR Secretariat / 5/4/2017 10:22:38 AM

    The EMA have published guidance for marketing authorisation holders over how Brexit will affect their responsibilities. Particularly, they remind companies that marketing authorisation holders must be…

    Changes to freelance tax status

    By ICR Secretariat / 4/4/2017 12:56:26 PM

    In the Autumn Statement 2016, the chancellor confirmed that, in the public sector only, IR35 status will be determined by the client, not the contractor.

    If a client decides IR35 does apply, the cont…

    FDA reveals recommendations for generics and biosimilars

    By ICR Secretariat / 3/15/2017 1:19:59 PM

    The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics.