The New ICH GCP E6 R2 Guideline
Short course
In The Rembrandt Hotel, London
Description
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Type
Short course
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Level
Intermediate
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Location
The rembrandt hotel, london
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Duration
2 Days
NEWLY FINALISED!
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.
Facilities
Location
Start date
Start date
Start date
About this course
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
The course is relevant for professionals working in clinical research/clinical operations, regulatory affairs and pharmacoviglance in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites including investigator initiated studies involved in clinical trials. It will also be of interest to those departments who liaise/support clinical trial personnel (such as clinical trial supply, quality assurance, document management, legal, and all other professionals who want to know more about the new ICH GCP (R2) guideline.
Reviews
Subjects
- Risk
- Monitoring
- Quality
- Clinical Trial
- IT risk
- Quality management
- Quality Training
- Management
- Medical
- Training
Teachers and trainers (1)
Dr Laura Brown
Course Director, School of Pharmacy
Course programme
Introduction and objectives
Understand the background to ICH GCP (R2) guideline
- Why the revision?
- ICH and its importance
- The links of ICH GCP (R2) and other relevant EU and FDA guidelines and documents including the new EU Clinical Trial Regulation
Overview of the changes of the new ICH GCP (R2) guideline and how these will impact on clinical trials
- New definitions
- New sections on investigator responsibilities and oversight
- Significant changes to sponsor oversight
- Quality management
- Risk-based monitoring
- Computer validation
- Serious breaches
- Clarification of the contents of the TMF
- Implications for changes to processes and SOPs
- A new quality standard of ICH GCP (R2)
Sponsor implementation
Quality management
- Implementing a quality management system
- Critical processes and data identification
- Risk process: identification, evaluation, control, reporting, communication, mitigation
Oversight of CROs
- New requirements for sponsor oversight of vendors/CROs
- Implications for the selection, contracts, management and performance of CROs
- Practical approaches to how to demonstrate sponsor oversight compliance
Risk-based monitoring
- Definitions of risk-based monitoring
- Risk-based monitoring approaches
- Virtual clinical trials case study
- Monitoring plans
- Remote monitoring of informed consent – case study
Electronic systems
- Validation processes
- Certified copies of documents
- SOPs needed for electronic trial data handling
Serious breaches of GCP
- What are serious breaches and how should these be reported?
- Case study examples of serious breaches
- How to carry out and document corrective and preventative action (CAPA) to comply with ICH (R2) to manage serious non-compliance of GCP
Investigator study site oversight
- Investigator responsibilities for supervision of individuals activities which are delegated
- Ensuring appropriate qualifications of staff
- Responsible for trial data including source data is attributable and complete
Trial Master File and preparation for inspection
- What additional documents should the TMF contain?
- Maintaining a record of the location of essential documents irrespective of storage system or media
- Investigator control of essential documents
- EMA draft TMF expectations for the TMF including e-TMF
Summary and close
The New ICH GCP E6 R2 Guideline