Overview:
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. 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 going to be areas inspectors will be focussing on.
Why should you Attend: This informative session will cover these new requirements for auditing clinical trials, evaluate the changes and understand how these impact on auditors. 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.
Areas Covered in the Session:
Understand the new requirements of the updated ICH GCP R2 guideline for auditors
Hear about the future ICH major revision planned
Review the new requirements for what auditors should look for Sponsor Oversight, Risk based quality systems, risk based monitoring, data management, Investigator site audit, the trial master file
Review best practice of these additional new GCP requirements for auditors
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. 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 going to be areas inspectors will be focussing on.
Why should you Attend: This informative session will cover these new requirements for auditing clinical trials, evaluate the changes and understand how these impact on auditors. 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.
Areas Covered in the Session:
Understand the new requirements of the updated ICH GCP R2 guideline for auditors
Hear about the future ICH major revision planned
Review the new requirements for what auditors should look for Sponsor Oversight, Risk based quality systems, risk based monitoring, data management, Investigator site audit, the trial master file
Review best practice of these additional new GCP requirements for auditors
Who Should Attend
- Auditors
- QA Professionals
- Clinical Research/Clinical Operations
- Regulatory Affairs
- CRO, Regulatory Authorities
- Clinical Trial Personnel
- Quality Assurance
- All other Professionals who want to know more about the new ICH GCP (R2) guideline
