HESI & SPS virtual training opportunity

  • Start Date/Time :
  • End Date/Time :
  • Location : Virtual Training, HESI & SPS

Registration is open! 21-22 June 2022. The Health and Environmental Sciences Institute (HESI) & Safety Pharmacology Society (SPS) present a new, virtual training opportunity: A closer look at the new ICH E14/S7b Q&A and Training Materials.

This training is being provided complimentary for SPS and HESI members, and offered to nonmembers for $99.00 USD. Registration Deadline 20 June 2022.

View the full agenda here

Register here

Training Goals:

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: a. Are the studies of reasonable quality with the appropriate quality measures? b. 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.

 

 

Contact Us

Health and Environmental Sciences Institute (HESI)

hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859

740 15th Street NW, Suite 600
Washington, DC 20005

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