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ICH E6 Review & Update Course

Course Information

This course is designed to provide comprehensive guidance and practical help for those who have an interest in understanding the new ICH E6 Guideline

Course Outcomes:

- Demonstrate understanding of the new requirements of the updated ICH GCP guideline
- Appreciate the challenges in implementing the new guidance
- Review the new requirements for Sponsor, CROs, and investigators
- Share best practice of these additional new GCP requirements for running clinical trials

By the end of the course delegates will be able to:

- Understand the new requirements for running clinical trials
- Evaluate the changes
- Discuss how these changes should have been implemented.
- Meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally

Course Tutors

Laura Brown
Laura Brown Consulting

Course Material

Following requests from attendees of previous RQA events we are pleased to offer seminar material in PDF format for delegates attending this seminar. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post seminar
  • Environmental benefits – less paper being used per seminar

The material will be emailed in advance of the seminar and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

Additional Requirements 
(not included in course fees)

Accommodation is available at Novotel Heathrow by booking directly with the hotel.

Course Programme

9.00 Registration
9.30 Introductions and Scope of the Course
Understand the group requirements and the tutor’s background and experience
9.45 Background and Setting the Scene
Understanding the context to ICH GCP (R2) guideline
10.30 Overview of the Changes of the New ICH GCP (R2) Guideline
How these changes will impact on clinical trials
11.00 Break
11.15 Sponsor Implementation
Practicalities for implementation for roles, responsibilities and documentation
11.30 Workshop
Quality management and Quality Risk Management considerations
12.15 CRO Oversight
Practicalities, roles and responsibilities discussion
13.00 Lunch
14.00 Risk-based Monitoring
Discuss the requirements and practicalities for risk-based monitoring and sharing experiences of how this should be audited
14.45 Electronic Systems
Implications considered
15.00 Break
15.15 Investigators Study Oversight Responsibilities
Discuss the implications for the investigator and auditing sites
15.30 Trial Master File
Review the impact of the trial master file and preparation for inspection
16.00 Question Time
A chance for questions on the practicalities of ICH GCP R2
16.30 Close of course

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