by GCP Central | Dec 12, 2024 | updates law & regulations
Most likely, the International Council for Harmonisation (ICH) will release the updated Good Clinical Practices (E6) R3 guidelines early 2025. This change represents a significant shift in the setup of the guideline that has been around since 1996. Since the...
by GCP Central | Jun 5, 2024 | updates law & regulations
The update to the ICH GCP E6 (R3) guideline is currently in its final stages. Step 3 and 4 are, as currently discussed in the ICH Assembly meeting in Japan, expected around October 2024. If that timeline indeed is met, the updated Good Clinical Practice Principles and...
by GCP Central | Aug 22, 2023 | updates law & regulations
What is coming with ICH GCP R3? Since ICH GCP (or officially, ICH E6 R1) was first drafted more than 20 years ago, the complexity of clinical trials has increased, with the design of trials, technology use, and data quality and collection changing to the evolving face...
by GCP Central | Jul 20, 2023 | updates law & regulations
Since ICH-GCP (or officially, ICH E6 R1) was first drafted more than 20 years ago, the complexity of clinical trials has increased, with the design of trials, technology use, and data quality and collection changing to the evolving face of research. The...
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 | Jun 13, 2018 | GCP Central News, updates law & regulations
On June 14, 2017 the new ICH GCP is in effect: Addendum R2. In hospitals, pharmaceutical companies and CROs, the agreement has been made that a GCP training certificate obtained is valid for 2 to 4 years. But what if, in the meantime the legislation is updated as in...
by GCP Central | Mar 9, 2017 | GCP Central News, GCP Central Products, updates law & regulations
We at GCP Central are always looking for new ways to doWMO/GCP training in an even more efficient way. For students, this by only teaching them what is relevant at that moment. For research agencies and managers, by providing reports and insight into training...
