by GCP Central | Oct 25, 2022 | GCP Central News
This is the first in a series of articles where GCP Central goes in-depth into the challenges, learnings, and critical findings of implementing the new European Clinical Trials Regulation (EU CTR). In this instalment, we reflect on the Clinical Trials Information...
by GCP Central | Jul 15, 2022 | GCP Central News, updates law & regulations
In the past few months, 2 new regulations have been put into place in the world of clinical trials. The EU Clinical Trials Regulation and the Medical Devices Regulation (MDR) (EU 2017/745) have been implemented. This has created a new need for training teams to...
by GCP Central | Mar 30, 2022 | GCP Central Products
The transition from the previous MDD to the new MDR brings a period of change. But what impact will this have on research and more importantly, what are the issues faced with non-compliance? With over 20 years of industry experience in biotech, pharma, and medical...
by GCP Central | Jan 31, 2022 | GCP Central News
Today’s the day the EU CTR comes into effect. This new legislation will majorly impact organizations involved in the design and implementation of clinical trials. Our previous blog covered the fundamentals of this new regulation and what made it different from...
by GCP Central | Jan 26, 2022 | GCP Central Products
On the 31st of January, 2022, the European Commission’s new clinical trial legislation will come into effect. With the hope of creating a better environment to conduct clinical trials within the EU, the European Clinical Trials Regulation (EU CTR...
by GCP Central | Dec 13, 2021 | GCP Central News
On November 1, 2021, the new Local Feasibility Procedure and the use of the Research Institute Suitability Statement (VGO) will be in place. This is mandatory for drug research. We spoke with Sanofi’s Thera Max-Mos, Head Clinical Study Unit ai, NL, to...
