ICH Q3E best practice for navigating data gaps and building defensible E&L justifications

How do you build a defensible extractables and leachables (E&L) justification when the data is incomplete?

As the ICH Q3E guideline develops, expectations for E&L risk assessment are becoming clearer, particularly around how safety thresholds are derived and how decisions are justified when evidence is limited.

This webinar focused on how these expectations translate into practice, and how to approach E&L assessments when the available evidence does not give a single clear answer.

We heard from the experts shaping and applying ICH Q3E

Dr Patricia Parris, Toxicology Impurity Risk Management, Research Fellow at Pfizer – Insight into the development of Q3E, including the rationale behind safety thresholds and how weight of evidence supports justification
Dr Lance Molnar, Head of Nonclinical Operations and Risk Assessment, Viatris – A real-world case study showed how E&L assessments are applied in practice, and how workflows can be improved beyond manual approaches
Jessica Halliday – Application Scientist, Lhasa Limited – An applied perspective on addressing data gaps using read-across to support point of departure (PoD) identification and overall risk assessment

What attendees learnt

Through regulatory insight, real-world application, and applied workflow, this session showed how to:

- - Apply Q3E expectations within E&L risk assessments
  - Use weight of evidence (WoE) to support your decisions
  - Derive and justify safety thresholds, including PDEs
  - Address data gaps using read-across and in silico approaches
  - Build clear, scientifically grounded justifications

Why attendees registered

- - Understand the rationale behind Q3E safety thresholds
  - See how E&L assessments are applied in practice
  - Gain approaches for working with limited evidence
  - Explore how in silico methods support consistent decisions
  - Leave with a clearer way to build defensible justifications

Who attended

This webinar is relevant for scientists responsible for E&L risk assessment and justification, including those working in:

- Extractables and leachables
- Toxicology and safety assessment
- Regulatory and quality functions

Put defensible E&L read-across into practice

If your team is preparing for ICH Q3E and needs a clearer way to justify E&L safety decisions, Acrostic can help put read-across into practice. The platform supports analogue identification, evidence review and structured expert rationale, helping toxicologists make more consistent, transparent and defensible decisions when experimental data is limited.