ICH E6 (R3): Guide to Understanding and Implementation

Summary

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 are likely to outweigh the costs associated with change. It introduces updates that aim to make the guidelines more flexible and adaptable, encouraging a risk-based approach.

We have organized a comprehensive day of learning, where you 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, which will make your clinical trials more effective and less resource-intensive.

The course will feature a panel of lecturers representing regulatory authorities and the pharmaceutical industry. This format allows for constructive discussions and valuable outcomes.

The day will include workshop sessions, with the intention of making the experience as interactive as possible.

Keywords

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