by chuck_ltd | 3 Nov, 2017 | CHCUK News & Articles, CHCUK NIS Database, News, NIS, NIS Considerations Report
Non-Interventional Studies… Q. What is the Biggest Challenge? A. Working out the regulatory requirements for your study! Finding out what’s needed to run a non-interventional study shouldn’t be difficult, but it is! We’ve taken the pain out of that process by...
by chuck_ltd | 6 Jul, 2017 | CHCUK News & Articles, Medical Apps, Medical Devices, News
Source: Osborne Clarke It is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its marketing. But deciding exactly when software will be categorised as...
by chuck_ltd | 3 Apr, 2017 | 21 Century Cures Act, Cures Act, EU Clinical Trials Regulation, Pragmatic Trials
It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting...
by chuck_ltd | 3 Mar, 2017 | CHCUK News & Articles, News, NIS, NIS Considerations Report, Regulatory Intelligence
The German Bundestag adopts Fourth Act on the Amendment of the German Drug Act and Other Provisions Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health The 4th law on the amendment of the German Drug Act came into force on...
by chuck_ltd | 3 Mar, 2017 | CHCUK News & Articles, NIS, NIS Considerations Report
Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health An important modification of the French research law framework occurred in November 2016 with the coming into force of decree No. 2016-1537. The law describes the modalities for...
