A Closer Look at the New ICH E14/S7B Q&As and Training Materials, hosted by HESI and SPS

This event is an ICH Recognised Training Programme and a recording from the live event held in June 2022. The content focuses on the ICH E14/S7B new Q&As and associated Training Materials.

Target Audience

The target audience includes all sponsors (small and large; other stakeholders in pharma), safety pharmacologists and toxicologists participating in the delivery of the nonclinical data, clinicians, and regulators.

Learning Objectives

  1. Recognize when nonclinical data may be used in the regulatory QT assessment, including understanding the difference between 5.1 and 6.1.
  2. Recognize quality hERG and in vivo studies:
    • Are the studies of reasonable quality with the appropriate quality measures?
    • Is the study consistent with the performing lab’s experience with reference agents?
  3. Gain familiarity with clinical exposure definitions and how margins are defined to understand the hERG and in vivo margin. 
  4. Recognize a double-negative nonclinical package. 
  5. Understand what information is needed to justify the integrated QTc risk assessment. 
  6. Understand that there can be mitigation around some of the nonclinical study features. 
  7. Understand timing of various assays and how to progress to clinic. 
  8. Understand the flexibility of these guidelines and what alternatives may be implemented.
Course summary
Course opens: 
06/24/2022
Course expires: 
01/31/2023
Cost:
$49.00
Rating: 
0

Overview of the ICH E14/7B Q&A Training Materials

  • Introduction - David Strauss, FDA, United States
  • Integrated Risk Assessment - Zhihua Li, FDA, United States
  • In Vitro - Derek Leishman, Lilly
  • In Vivo - Hugo Vargas, Amgen
  • Conclusions - David Strauss, FDA, United States

Case Studies and Scenarios for 5.1

  • Moderator - Christine Garnett, FDA, United States
  • Speakers - Corina Dota, EFPIA & Wendy Wu, FDA, United States
  • Topics covered: E14 Pathways and New Options, Clinical Scenarios,
  • Integrated Nonclinical Data (in vitro & in vivo)

Case Studies and Scenarios for 6.1

  • Moderator - Christine Garnett, FDA, United States
  • Speakers - Hugo Vargas, Amgen & Flora Musuamba Tshinanu, FAGG-AFMPS, Europe
  • Topics covered: E14 Pathways and New Options, Clinical Scenarios, Integrated
  • Nonclinical Data (in vitro & in vivo)
  • Summary of integrated risk data

David Strauss, FDA, United States

Zhihua Li, FDA, United States

Derek Leishman, Lilly

Hugo Vargas, Amgen

Christine Garnett, FDA, United States

Corina Dota, EFPIA

Wendy Wu, FDA, United States

Flora Musuamba Tshinanu, FAGG-AFMPS, Europe

 

Price

Cost:
$49.00
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