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6th Annual Extractables & Leachables Summit 2026

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Extractables and Leachables
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Conference Overview

The 6th Extractables & Leachables Summit 2026 is a premier two day event bringing together global experts from pharma, biotech, medical devices and regulatory agencies to discuss the latest trends, challenges and innovations in E&L science.

Day 1 focuses on regulatory frameworks, advanced analytics and digital transformation, featuring updates on ICH Q3E, USP, FDA and EMA guidelines, breakthroughs in high resolution analytical techniques and the integration of computational toxicology and predictive modelling. Attendees will also explore methodologies for assessing cumulative E&L effects, aligning strategies across the product lifecycle and implementing sustainable, green testing practices.

Day 2 delves into biologics, single use systems and medical devices, covering sterility and standardization, analytical strategies for device-associated leachables, real world case studies and management of secondary leachables in complex biologics. Additional sessions address PFAS risk assessments, route specific packaging safety and immunotoxicology for safer, compliant products.

What We Will Discuss

  • Global Regulatory Frameworks & Harmonization.
  • Investigation of Leachable NDBA and other small molecule nitrosamines in infusion bags by an ultra-sensitive dynamic headspace GC-MS/MS method.
  • Transitioning from PQRI Recommendations to ICH Q3E: Key Changes in E&L Risk Assessment.
  • Characterization of structural clusters for Extractables and Leachable (E&L) risk assessment.
  • Cumulative E&L Effects and Combined Risk Assessment.
  • Lifecycle Integration of E&L Strategies.
  • Digitalization & AI Modeling in E&L.
  • Sustainability in E&L Testing.
  • Single Use Systems & Process Equipment.
  • E&L in Medical Devices & Their Risk Assessment.
  • Case Studies: Real World Challenges & Solutions.
  • Biologics and Secondary Leachables.
  • Advanced PFAS Detection & Migration Studies.
  • Packaging and Route Specific Risks.
  • Immunotoxicology & Sensitization Risks.
  • Low Extractable Materials & Next Generation Polymers.

Who Is It For?

CxO, VPs, Directors, Heads, Managers of

● Extractables and Leachables/ E&L
● Analytical Chemistry
● Risk Assessment
● Drug Development/ Drug Substance
● Analytical Development
● Good Laboratory Practice (GLP)
● LC-MS/ Mass Spectrometry
● Packaging & Labelling
● Materials Science
● Regulatory Affairs & Compliance
● Bioprocessing/ Bioproduction
● Manufacturing Science

Agenda 6th Annual Extractables & Leachables Summit 2026

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

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Speaking Companies

Previous Events
5th Annual Extractables & Leachables Summit 2025
February 27, 2025
This event is designed to learn about the latest methods for testing and analyzing pharmaceutical Extractables and Leachables. [Recording: 16 video sessions].
Expired
[•REC] - €345
4th Annual Extractables & Leachables
4th Annual Extractables & Leachables Summit 2024
March 7, 2024
What is next in testing and analyzing for extractables and leachables in biopharmaceutical development and release? [Recording: 18 video sessions].
Expired
[•REC] - €295
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Speaker Board
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Craig Van Bruggen
Craig Van Bruggen
Principal Chemist
Element Materials Technology
Valeria Mazzoni
Valeria Mazzoni
E&L Project Coordinator
Neotron S.p.A.
Aeshna Amin
Aeshna Amin
Manager, E&L
Baxter, ELSIE
Ron Brown
Ron Brown
Principal Toxicologist
Risk Science Consortium
Samuel Kikandi
Samuel Kikandi
Deputy Director - Principal Engineer
Sanofi Inc.
Martyn Chilton
Martyn Chilton
Principal Scientist / Scientific Consultant
Lhasa Limited
Jure Hren
Jure Hren
Senior Expert Science & Technology
Novartis
Simone Carrara
Simone Carrara
E&L and packaging testing BUMa
Eurofins BPT
Daniele Ubbiali
Daniele Ubbiali
Project Leader
Eurofins BPT
Pujitha Gourabathini
Pujitha Gourabathini
Quality Assurance Manager
Becton Dickinson and Co.
Dvir Doron
Dvir Doron
Director, Chemical Toxicology Team Leader
Teva Pharmaceutical Industries Ltd.
Alina Martirosyan
Alina Martirosyan
Sr. Scientific Manager Toxicology
B. Braun Melsungen AG
Will Parker
Will Parker
E&L Technology Manager
West Pharmaceutical Services
Ana Kuschel
Ana Kuschel
Principal Scientific Affairs
West Pharmaceutical Services
Candice Johnson
Candice Johnson
Senior Research Scientist
Instem
Dujuan Lu
Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
Etienne Michel
Etienne Michel
Global QA for E&L
GSK Vaccines
Marine Lepoutre
Marine Lepoutre
E&L Global SME
GSK Vaccines
Reinhard Stidl
Reinhard Stidl
Senior Toxicologist - Managing Director
Safetree Consulting e.U.
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Summit Agenda
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◆  Updates on ICH Q3E, USP, FDA and EMA guidelines; trends in global alignment and riskbased strategies.

◆  Preliminary Risk Assessment: Understand the importance of conducting a thorough risk assessment before analytical testing.

◆  Risk Analysis Process: Learn about the key steps in risk analysis and the relevant documentation required for regulatory submissions.

◆  Extractables Untargeted Approach: Gain insights into the development of analytical protocols, solvent selection, and the definition of Acceptable Exposure Threshold (AET).

◆  Toxicological Evaluation: Learn how to integrate toxicological risk assessment with analytical testing for comprehensive safety evaluations.

◆  Leachables Untargeted and Targeted Approaches: Understand the different strategies for analyzing leachables, including both untargeted and targeted methods.

◆  Case Study Examples: Explore a practical case study of E&L testing illustrating the real-world application of these principles.

NeotronNeotron
Neotron S.p.A.., IT

Speakers:

◆  Comparing E&L risk assessment practices in OINDP, PDP, and ODP.

◆  Systemic and local toxicity thresholds across different routes of administration.

◆  Classification of E&L compounds and PDE calculations.

◆  Illustrative case studies.

TEVATEVA
Teva Pharmaceutical Industries Ltd., IL

Speakers:

◆  Biological Risk Assessment of Medical Devices within the Risk Management Framework.

◆  Role of Toxicological Risk Assessment in the Biological Risk Assessment.

◆  Toxicological Risk Assessment of Chemical Constituents of Medical Devices – Practical Application of ISO 10993-17:2023.

B.Braun-MelsungenB.Braun-Melsungen
B. Braun Melsungen AG, DE

Speakers:

Toxicity data are critical to evaluating the risks associated with patient exposure to E&L compounds released from medical devices and pharmaceutical packaging. However, when the toxicity data are unavailable, New Approach Methods (NAMs), including in silico (computational) models, are promising tools to predicting the toxicity of E&L compounds without relying solely on traditional animal testing. This presentation will not only describe the use of the Read Across and QSAR in silico models, but will also provide practical guidance on how to use model-derived predictions of toxicity in a safety assessment of E&L compounds.

Risk Science ConsortiumRisk Science Consortium
Risk Science Consortium, USA

Speakers:

◆  Exploration of the E&L chemical space in terms of structural information, physicochemical properties and toxicity data using a compiled dataset of potential E&Ls from public and proprietary sources.

◆  A comparative analysis of chemical properties and clusters between the public dataset and a proprietary dataset derived from NDAs and ANDAs.

◆  Discuss variability in chemical features, physicochemical properties, and toxicity between and within clusters.

◆  Assess the coverage of an existing toxicological database for applicability to E&L structures and to support read-across assessments for PDE derivation.

InstemInstem
Instem, USA

Speakers:

◆  Understanding the new guidance from US FDA on leachable N-nitroso-Dibutylamine (NDBA) and other small molecule nitrosamines in infusion bags.

◆  Investigation of the root causes of the NDBA from infusion bags with printed pouches.

◆  An ultra-sensitive dynamic headspace GC-MS/MS method to detect NDBA and other small molecule nitrosamines with a LOQ of 0.1 ppb and its application to infusion bags with printed pouches.

SGS-Health-ScienceSGS-Health-Science
SGS Health Science, USA

Speakers:

◆  HPLC to UPLC method transition.

◆  Method development with standard mix and extractable study samples.

◆  Retention time normalization by algorithmic prediction.

◆  HPLC to UPLC RRF alignment.

EurofinsEurofins
Eurofins BPT, IT

Speakers:

◆  Overview: Simulated solutions for leachable studies can be instrumental for extractable and leachable (E&L) risk assessment of certain pharmaceutical and medical device applications.

◆  Case study: A simulated leachable approach was utilized for evaluation of a pharmaceutical application where the final drug product was unavailable for testing.

◆  Applications: Cover how simulation solutions can be used in other extractable and leachable (E&L) applications.

◆  Proper Design: Discuss how to properly create simulation solutions to simulate a contact product’s extraction propensity.

Element-Materials-TechnologyElement-Materials-Technology
Element Materials Technology, USA

Speakers:

◆  Definition of Low AET.

◆  Challenges.

◆  Solutions/alternatives.

ELSIE_ELSIE_
ELSIE, IN

Speakers:

◆  Risk-Based Approach: Strategies for prioritizing E&L testing based on product type, route of administration, and patient risk.

◆  Analytical Methodologies: Advances in detection and quantification of extractables and leachables in complex matrices.

◆  Case Studies & Best Practices: Practical examples of E&L programs for biologics and C&GT products.

EurofinsEurofins
Eurofins BPT, IT

Speakers:

◆  Learn about the diversity of administration materials.

◆  Hear how formulation impacts leachables from administration materials.

◆  Understand the role of administration materials in leachables profiles.

NovartisNovartis
Novartis, SI

Speakers:

◆  Provide an overview of the key challenges when assessing the safety of E&Ls and the workflows available to guide assessors.

◆  Introduce an in silico framework which addresses mutagenicity, local toxicity and systemic toxicity to produce a scientifically robust safety assessment.

◆  Present a case study which uses this framework to demonstrate the safety of a leachable, and show the value added by using databases, (Q)SARs and read across.

Lhasa-LimitedLhasa-Limited
Lhasa Limited, UK

Speakers:

◆  New toxicological concepts in the ICH Q3E draft guideline.

◆  Less than lifetime considerations for safety thresholds.

◆  Review of PDE and Acceptable Exposure values for Class 3 leachables.

◆  Case study: Rubber oligomers.

Safetree-ConsultingSafetree-Consulting
Safetree Consulting e.U., AT

Speakers:

◆  Why cumulative exposure matters in biological safety: How cumulative and combined chemical exposures across materials, components, and use durations influence overall patient risk, and why traditional single source E&L assessments don’t fully capture that picture.

◆  Bridging chemistry, toxicology, and device risk: A practical, ISO aligned approach for integrating chemical characterization, toxicological thresholds, and clinical use conditions into a unified cumulative exposure narrative.

◆  Methods for combined risk assessment: Strategies for evaluating additive, synergistic, or repeated use E&L effects across multi material systems, drug contact pathways, and complex delivery platforms.

◆  Operationalizing cumulative E&L thinking: How manufacturers can embed cumulative exposure considerations into risk management files, biological evaluation plans, and regulatory ready documentation that withstands scrutiny.

Becton-DickinsonBecton-Dickinson
Becton Dickinson and Co., USA

Speakers:

Summary: This presentation addresses critical industry challenges in conducting swift Extractables and Leachables (E&L) Qualification of Pharmaceutical Product Contact Single Use Systems (SUS) in pharmaceutical manufacturing. As SUS adoption accelerates, the session demonstrates how manufacturers and end users can achieve rapid qualifications while maintaining rigorous safety standards and full regulatory compliance with FDA, EMA, and other global health authorities. The presentation provides practical implementation strategies centered on industry-standard risk assessment models, particularly navigating key regulatory chapters USP <665>, ICH Q3E, and ISO standards guidelines while tapping related BPOG protocol strategies. By emphasizing a seamless qualification process that balances speed with scientific rigor, attendees will gain tools to optimize E&L workflows, reduce time-to-market, and maintain the highest standards of patient safety and product quality. The content is particularly relevant for quality assurance professionals, regulatory affairs specialists, and manufacturing engineers and scientists working with single-use systems in pharmaceutical and biopharmaceutical production.

SanofiSanofi
Sanofi Inc., USA

Speakers:

◆  Will give an overview of the raw materials used in butyl rubber manufacturing, and explain how the selection of raw materials affects the extractables of the manufactured component.

◆  Leachables data of the new formulation will be presented alongside data of other formulations.

◆  How will the new ICH Q3E guideline affect the data needed to perform a good risk assessment, and how might suppliers help?

WestPharmaWestPharma
West Pharmaceutical Services, USA/DE

Speakers:
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Registration Tickets

10% discount for 1 person registered, 15% discount per person if 2-3 bookings, and 20% discount per person if 4+
To receive a discount coupon, email us at info@uventia.com or submit a REQUEST BROCHURE

The discount is valid until 13th of February 2026

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2 Days Ticket + Recording
€595

Full access to the 2 days online event.

Recording of 2 days event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

1 Day Ticket + Recording
€415

Full access to the 1 day online event.

Recording of 1 day event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

2 Days Recording
€495

Recording of 2 days event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

To register to the summit as a Delegate, complete the registration form. After submission, you will receive confirmation and invoice. Registration for the virtual event covers access to all online material in the Proceedings including keynotes, PDF presentations and papers, posters, and delegate list with contacts as well as video recordings of speakers' speeches.

If you need more information, please contact us at info@uventia.com

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