ICH-GCP E6 R3 – The Coming Changes?

A detailed review of the proposed changes to ICH-GCP E6 prior to any adjustments that may be implemented based on any feedback from public consultation.

Price: $188

FOCUSED HOURS: 2.5

SCHEDULED DATE: 14/05/2024 | 12:00 am GMT

Knowledge Area: gcp

Type: scheduled-webinar

Trainer: Steven Bukvic |

Overview

This engaging webinar will provide you with a brief background to the development of ICH-GCP E6, a brief overview of the current structure of ICH-GCP E6 R2, an overview of the proposed structure of ICH-GCP E6 R3, followed by a detailed review of the key proposed changes within each section of the proposed R3 version. The webinar concludes with some key suggestions  for sponsors / CROs about key areas they should focus on in preparation for the implementation of the final ICH-GCP E6 R3 version.

The webinar is extremely well structured, easy to follow, with frequent polls, examples of some feedback currently in the public domain, as well as useful hints and tips. The webinar includes a 15 minute break.

The webinar is presented by our experienced instructor, Steven Bukvic, who has almost 25 years experience as a trainer in the international arena. With a clear British accent, Steven has adjusted his speech over the years to accommodate the needs of non-native English speakers. He is regularly complimented for his clear, understandable, and friendly delivery style.

Webinar Content

  • Introduction
  • Webinar Objectives & Structure
  • A Brief History of ICH-GCP E6
  • The Drivers & Rationale for Changes (R2 to R3)
  • The New ICH-GCP E6 R3 Harmonized Guidelines (v 19-MAY-2023)
  • Points for Consideration
  • Introduction to the ACROSS Global R2-R3 Mapping Tool
  • Questions & Clarifications