ICH E6 (R3) – Site staff's guide to understanding and implementation

Summary

This one-day course is designed for employees working with clinical development and focuses solely on the site implications of the new guideline

The new ICH E6 (R3) guideline represents a significant change in clinical trial management.

When implementing this new guideline, you need to reconsider your current processes.

While ICH E6 (R3) may present challenges, it's a guideline that the industry should strongly consider adopting in due course. The potential benefits of implementation will likely outweigh the costs associated with change. It introduces updates to make the guidelines more flexible and adaptable, encouraging a risk-based approach.

We have organised a comprehensive day of learning, during which you, as site staff, will gain insights into what it takes to comply with the new guidelines.

Among other topics, you will learn to implement a risk-based approach, making your clinical trials more effective and less resource-intensive.

Featuring lecturers from regulatory authorities and the pharmaceutical industry, this course creates an environment for constructive discussions and valuable outcomes.

The day will include workshop sessions to create a highly interactive learning experience.

 

Keywords

• ICH-GCP
• Quality by design
• Risk management
• Data governance
• Feasibility