POSTED BY ALICE SIMPSON | 3 MARCH 2022 ABPI Consultation on new industry principles for the use of health data The ABPI is proposing a new set of principles to improve public trust and transparency around the use of health data. Read more Share this article Bookmark this page 2 min read data protection Life sciences medical devices pharmaceuticals
POSTED BY ISABEL TEARE | 7 FEBRUARY 2022 Good Machine Learning Practice for medical devices We look at the Good Machine Learning Practice guidance for medical devices drawn up jointly by regulators in the US, Canada and the UK. Share this article Bookmark this page 3 min read
POSTED BY JOHANNES ARENS | 20 DECEMBER 2021 Is pharmaceutical research and development work obvious? Pharmaceutical research and development activity involves substantial investment and ingenuity. Should this be taken for granted when assessing the inventiveness of pharma patents? Share this article Bookmark this page 4 min read
POSTED BY JAMES FRY | 17 DECEMBER 2021 Cell and gene therapies: how to encourage and promote the move to market Share this article Bookmark this page 4 min read
POSTED BY ISABEL TEARE | 12 NOVEMBER 2021 The ABPI sets out its stall for the future of medicines regulation We take a look at the ABPI's Vision Paper on UK medicines regulatory policy and global influence in a post-pandemic world. Share this article Bookmark this page 2 min read
POSTED BY ISABEL TEARE | 29 SEPTEMBER 2021 An opportunity to shape the UK medical devices regime The EU is now well on its way to completing the roll out of its new regulatory system for medical devices. The Medical Devices Regulation is now in force, and the In Vitro Diagnostics Regulation will follow next May... Share this article Bookmark this page 3 min read
POSTED BY ISABEL TEARE | 24 AUGUST 2021 EU clinical trials portal to go live in early 2022 It has been a while, but the EU Clinical Trials Information System (CTIS) is set to go live on 31 January 2022. This means that the system set up in 2014 under the Clinical Trials Regulation will finally come into effect. Share this article Bookmark this page 2 min read
POSTED BY ISABEL TEARE | 29 JULY 2021 UK regulator cracks down on anti-competitive practices UK watchdog, the Competition and Markets Authority (CMA), is coming down hard on anti-competitive pricing practices. Following hot on the heels of fines totalling over £260m for competition breaches relating to the supply of hydrocortisone tablets... Share this article Bookmark this page 2 min read
POSTED BY ISABEL TEARE | 8 JULY 2021 A new subsidy control system Simon Elsegood explains how this will change public sector investment aimed at developing the economy, following the UK's departure from the EU... Share this article Bookmark this page 1 min read
POSTED BY ISABEL TEARE | 6 JULY 2021 UK plans to boost pharmacovigilance and data collection on medicines The UK Government has published draft legislation targeting a major restructuring of the National Health Service. This will see the abolition of CCGs (Clinical Commissioning Groups) and the creation of statutory Integrated Care Systems (ICSs). Share this article Bookmark this page 2 min read
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