Key Take Away:
This webinar will review the key changes to ICH E6 R2 GCP, discuss the major challenges an organization might encounter with the revisions to ICH E6 R2 GCP, options to consider for implementation strategies and the unification of approval from multiple countries.
During this webinar, attendees will expand their current knowledge of the proposed revisions to ICH E6 GCP (Good Clinical Practice), this includes a general review of the major changes and how to address them.
We will discuss key topics such as clinical monitoring, software validation, quality management, and risk management. As we dive into the changes we will discuss potential implementation strategies as well as challenges one might encounter during the change process.
Understanding and reviewing the updates in advances will allow your organization to take the necessary steps to be prepared for the upcoming changes.
By the end of the webinar, you will be familiar with the revisions to ICH E6 GCP as well as having a better understanding of how to effectively implement the necessary changes within your organization to be in compliance with the updates to ICH E6.
Why Should You Attend:
ICH E6 GCP (Good Clinical Practice) is being updated and the revision is due to be finalized in November 2016. Are you ready for the updates? Have you made adjustments to your processes to be in compliance?
This webinar will review the major changes to ICH E6 and discuss strategies to consider which will help bring your organization into compliance with the updates in ICH E6.
Make sure you understand the changes before they take effect rather than putting it off because the requirements will still be there waiting for you to address. Take this opportunity to understand the updates and begin preparing.
Areas Covered In This Webinar:
This webinar will provide attendees with the chance to expand their understanding of the upcoming revisions to ICH E6 R2 GCP (Good Clinical Practices). This includes an overview of the major changes to the guidance including critical topics such as: clinical monitoring, software validation, quality management, and risk management.
We will discuss various approaches to consider to address the changes proposed in E6. While reviewing the changes to the guidance and potential implementation strategies we will also discuss challenges one might encounter during the change process. Options will be reviewed on how to successfully breakthrough the change process.
During this webinar you to understand potential challenges the new updates may create and how to effectively implement changes to address them.
Also, we will review how the guidance now provides a unified standard for acceptance in multiple countries.
• Discuss the major changes to ICH E6 R2 GCP
• Discuss potential challenges with ICH E6 R2 GCP
• Discuss how the revisions to the guidance may impact your organization
• Review options to effectively address the changes being proposed in the guidance
• Discuss the unification of multiple countries for approval
Who Will Benefit:
• Sponsor Personnel
• Regulatory Affairs Staff/ Compliance Staff
• Clinical Quality Auditors
• Clinical Study Staff
• Clinical Monitors/ CRAs
• Quality Assurance Personnel
Dr. Susan Leister
Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc., with over 20 years of experience in the pharmaceutical and medical device industry. She is also faculty for both graduate and undergraduate studies at the University of Phoenix.
In addition to a bachelor’s degree in biochemistry and molecular biology, she has an MBA, a doctorate in organizational management with a focus on leadership, and holds certifications from the American Society of Quality (ASQ) as a Certified Quality Auditor and a Six Sigma Black Belt.
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