Past Free Webinar

Clinical Research 2.0? All you need to know about the planned ICH GCP revision.

Discover the future of Good Clinical Practice (GCP) and the highly anticipated ICH E6 Revision 3. Join our webinar as we explore changes to GCP principles, Sponsor and Investigator responsibilities, data governance in a digitizing industry, and the impact of ICH E6 Revision 3 on clinical trial conduct. Register now to stay ahead in the evolving world of clinical research.

Past Webinar

Clinical Research 2.0? All you need to know about the planned ICH GCP revision.

Past Webinar

Clinical Research 2.0? All you need to know about the planned ICH GCP revision.

Key takeaways

We will talk about the following elements:

How ICH E6 (R3) focuses on fit for purpose systems and processes to manage trial quality.
Enhanced requirements for more transparency and visibility of clinical trials.
Changes to Contract Research Organization (CRO) outsourcing requirements.
Emphasis on risk-based quality management and how it impacts clinical trials.
Which recommendations for centralized monitoring techniques have been implemented..
The use of technologies, handling of data governance and the role of study sites and investigators in their implementation.
Which changed requirements to essential clinical trial documents are suggested.

How ICH E6 (R3) focuses on fit for purpose systems and processes to manage trial quality.
Enhanced requirements for more transparency and visibility of clinical trials.
Changes to Contract Research Organization (CRO) outsourcing requirements.
Emphasis on risk-based quality management and how it impacts clinical trials.
Which recommendations for centralized monitoring techniques have been implemented..
The use of technologies, handling of data governance and the role of study sites and investigators in their implementation.
Which changed requirements to essential clinical trial documents are suggested.

Audience

This webinar is directed towards:

Sponsor staff involved in planning and execution of clinical trials
Contract Research Organization (CRO) staff involved in planning and execution of clinical trials
Investigators involved in, or planning to be involved in, clinical trials
Quality Assurance professionals working in clinical research.

Knowledge of basics of ICH E6 (R2) and the principles of GCP as they exist is expected, as these topics will not be covered extensively in the webinar.

Sponsor staff involved in planning and execution of clinical trials
Contract Research Organization (CRO) staff involved in planning and execution of clinical trials
Investigators involved in, or planning to be involved in, clinical trials
Quality Assurance professionals working in clinical research.

Knowledge of basics of ICH E6 (R2) and the principles of GCP as they exist is expected, as these topics will not be covered extensively in the webinar.