by chuck_ltd | 6 Jan, 2017 | Medical Devices
On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types. This guidance generally affirms the framework...
by chuck_ltd | 22 Dec, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News, Publication Guidelines
On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use...
by chuck_ltd | 14 Apr, 2016 | CHCUK News & Articles, News
The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the...
by chuck_ltd | 1 Feb, 2016 | CHCUK News & Articles
The law on modernisation of the French health system adopted on 17 December 2015 introduced, amongst other things, changes to the existing sunshine regulations which require industry to make public the existence of certain agreements with, and benefits provided to,...
by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Professional Standards, Real Word Evidence, Registry, Virtual Clinical Research
On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”). Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by...
