With the new ICH GCP E6 Revision 2 changes now finalised and needing to be implemented, it is important for organisations running clinical trials to understand the changes, the reasons behind them, and how they will be affected.
The new guideline includes a number of hot GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are aimed at increasing efficiency and reducing costs of clinical trials.
This course will cover these new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
Benefits of attending
- Understand the new requirements of the updated ICH GCP guideline
- Discuss challenges and opportunities in implementing the new guidance
- Review the new requirements for Sponsor Oversight, CROs, quality systems, risk based approaches and the TMF
- Share best practice of these additional new GCP requirements which will facilitate a broad and consistent international implementation of new methodologies for running clinical trials
- Introduction and objectives
- Understand the background to ICH GCP (R2) guideline
- Overview of the changes of the new ICH GCP (R2) guideline and how these will impact on clinical trials
- Sponsor implementation
- Quality management
- Oversight of CROs
- Risk-based monitoring
- Electronic systems
- Serious breaches of GCP
- Investigator study site oversight
- Trial Master File and preparation for inspection
- Summary and close
For more information about this conference visit https://www.researchandmarkets.com/research/md32lv/the_new_ich_gcp