Statistical Evaluation of Stability Data (ICH Q1E)

Participants will learn about ICH guideline Q1E, principles for stability data evaluation, and apply statistical methods to ensure consistent shelf-life compliance in future batches.
  • Tuesday
  • October
  • 14
  • 2025
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
IMG Joachim Ermer
Webinar Id: 61282
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview:

Establishing shelf life and suitable storage conditions for drug substances and drug products is an essential regulatory requirement and of utmost importance to maintain an appropriate quality, efficacy, and safety. Therefore, stability testing was the first topic of international harmonisation (ICH-Guidelines Q1). 

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of factors such as temperature, humidity, and light, to establish a retest period for the drug substances or a shelf life for the drug products, long-term storage conditions, as well as label requirements (for drug product). ICH guideline Q1E describes the use of stability data to extrapolate a retest period or shelf life in a registration application, thus allowing to claim a longer shelf life than covered by real stability data. 

Why you should Attend:

Participants will receive an overview on the ICH guideline Q1E and learn what are the principles and prerequisites of the evaluation and extrapolation of stability data. The statistical approach can also be applied to ensure that future batches will consistently meet the established shelf-life limits.

Areas Covered in the Session:

  • General Principles
  • Presentation of Results
  • Extrapolation prerequisites and conditions (room temperature and refrigerator storage)
  • General statistical approach
  • Individual batch analysis, poolability (combination of batches)
  • Other Designs

Who Will Benefit:

  • Analysts
  • lab supervisors and managers in Analytical Development and Quality Control responsible to plan, execute, or evaluate stability studies of drug substances or drug products
  • Quality Assurance and regulatory affairs representatives responsible to approve or evaluate stability data

Speaker Profile

Dr. Joachim Ermer is a biochemist with 30 years of experience in pharmaceutical analytics, including development products at Hoechst AG, global responsibilities as Director of Analytical Processes and Technology at Aventis, and head of Quality Control and head of QC Lifecycle Management Frankfurt Chemistry at Sanofi. From 2010 till 2020, he was also responsible for the central reference standard group and Global Reference Standard Coordinator of Sanofi. Since December 2020, he serves as consultant for topics of pharmaceutical analytics and Quality Control. Joachim Ermer is member of the USP Expert Committee “Measurement and Data Quality“, of the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and Advisory Board member of the ECA Analytical Quality Control Group.

He authored more than 60 publications on analytical topics and contributed to the USP General Information Chapter <1220> as well as other Stimuli Articles. He is editor and author of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005, 2015, 2024).