Event Details
- Forum
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This event has been completed
Essential GCP ICH E6 R2 Update - January 19, 2016 - January 20, 2016
- Rembrandt Hotel
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London, United Kingdom
- Introduction
- This is an international guideline which will update the current ICH GCP requirements globally. This course will cover the new guideline’s recommendations for applying advances in technology, risk based approaches for setting up and running clinical trials, increased sponsor oversight including of CROs, and enhanced requirements for recording and reporting data. These new approaches are aimed at increasing efficiency and also to reduce costs of clinical trials.
This course will enable you to meet the new international GCP standard to enable the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
The GCP update course will cover the new areas of the ICH GCP (R2) guideline including:
More efficient approaches to the design of clinical trials
Sponsor oversight requirements
New methodologies and technologies used in clinical trials
Risk-based approaches for setting up clinical trials
Risk-based management
Quality by design
Quality systems in clinical trials and clinical studies
Risk-based monitoring including centralized monitoring
Additional considerations for CRO management
Monitoring plans
Quality systems – including critical process and data identification
Risk identification, management and control
Electronic document management – the Electronic Trial Master File (TMF)
- Useful Links
- Reference link 1
- About Organiser
- Management Forum Ltd
- E: info@management-forum.co.uk
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