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Preparing for the ICH GCP E6 R3 update: What learners need to know

Preparing for the ICH GCP E6 R3 update: What learners need to know

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...
Implementation of ICH GCP E6 (R3) Update: Key Points and Process Overview 

Implementation of ICH GCP E6 (R3) Update: Key Points and Process Overview 

by GCP Central | jun 5, 2024 | updates law & regulations

The update to the ICH GCP E6 (R3) guideline is currently in its final stages. The guideline is being updated in 2 parts: First the Principles and Annex I are being updated and will go live, secondly Annex II will be released. The timelines of the ICH GCP R3 update was...
ICH GCP R3 – What should we expect? Part 2 

ICH GCP R3 – What should we expect? Part 2 

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...
ICH-GCP R3: What should we expect? Part 1 

ICH-GCP R3: What should we expect? Part 1 

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...
Checking In – Are You Inspection Ready with MDR and EUCTR?

Checking In – Are You Inspection Ready with MDR and EUCTR?

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...
What is your GCP certificate worth?

What is your GCP certificate worth?

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...
WMO/GCP training via your own learning portal? It’s possible

WMO/GCP training via your own learning portal? It’s possible

by GCP Central | mrt 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...

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