Impacts to RBQM and Monitoring of ICH GCP E6 (R3) and EMA Guideline Updates

Event Date: 1st August 2023

Event Time: 10:00am EDT/3:00pm BST

Watch now!

Date: August 1, 2023

Time: 10:00am EDT/3:00pm BST

Version R3 of the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline is now available for public consultation. The update is to address the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines to support regulatory and healthcare decision making.

During this webinar, we will explore the key changes and new text in Version R3 as it relates specifically to monitoring and RBQM. In addition, we will discuss updates to the EMA Guideline regarding computerized systems and electronic data in clinical trials. Finally, we will share how to create compliant procedures in accordance with the updated guidelines.

You might also be interested in

DIA China 2024 Annual Meeting


The upcoming DIA China 2024 Meeting will be held from May ...

Read more

2024 ASCO Annual Meeting


Step into a world of inspiration at the 2024 ASCO Annual M...

Read more

OCT Europe


With regulations ever changing and the innovative advancem...

Read more
Leading a new way

The latest from Caidya

Explore our news and updates as we liberate the clinical research process.


Caidya Achieves Medidata Rave TSDV Accreditation, Enhancing Clinical Trial Efficiency and Data Integrity

Raleigh, N.C., June 12, 2024 – Caidya, a leading provider...


Caidya Expands Global Presence with the Establishment of Caidya Canada Limited and New Office in Toronto

Morrisville, NC, USA, April 1, 2024 - Caidya, a leading...

Gene Therapy Development 2024

13th June 2024 to 14th June 2024
London, UK
Skip to toolbar