How to Prepare for ICH E6 (R2) GCP Revisions
About This Event
Description
This training program will discuss the revisions to ICH E6 R2 GCP. How these changes may impact your clinical trials in terms of cost and complexity. We will also review plans for risk management, human subject protection, and data integrity.
Objectives of the Presentation
Discuss the major changes to ICH E6 R2 GCP
Discuss potential challenges with ICH E6 R2 GCP
Discuss the unification of multiple countries for approval
Review frequently asked questions and answers
Determine how the revisions to the guidance impact your organization
Understand how to effectively implement ICH E6 R2 GCP
Why Should you Attend
During this training session, attendees will expand their understanding of the revisions to ICH E6 R2 GCP, this includes a general purpose of the changes to the guidance 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 to the guidance we will discuss potential implementation strategies as well as challenges one might encounter during the change process. The course will review how the guidance now provides a unified standard for acceptance in multiple countries. This session will also review some of the frequently asked questions.
At the end of the webinar, you will be familiar with the revisions to ICH E6 R2 GCP including having a better understanding of how to begin preparing your organization for the impending changes. This session will allow you to understand potential challenges with the new guidance and how to effectively implement them.
Areas Covered
Discuss key changes to ICH E6 R2 GCP
Discuss the major challenges with the revisions to ICH E6 R2 GCP
Implementation strategies for ICH E6 R2 GCP
Determining how the guidance impacts your organization
Review unification of approval from multiple countries
Who can Benefit
Regulatory Affairs staff/Compliance Staff
IRB/IECs
Clinical Quality Auditors
Clinical study staff
Clinical Research Associates
Site personnel
Sponsor personnel
For Registration
http://onlinecompliancepanel.com/webinar/HOW-TO-PREPARE-ICH-E6-R2-GCP-REVISIONS-501456/MAY-2016-ES-WORLDCONCAL
Note: Use Promo code VBTPK and get 10% off on registration (Valid till May 31st 2016)