OVERVIEW

6th Annual Extractables & Leachables Summit 2026 is organized by Uventia Global s.r.o. and will be held from Mar 05 - 06, 2026.

Description:
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.

KEY DATES

Event Start Date
05 Mar, 2026
Event Start Date
Event End Date
06 Mar, 2026
Event End Date

ACTIVITY SCHEDULE

Day 1March 05, 2026 | 3 Sessions
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  • 12:50 - 13:20Live IconLive

    Investigation of Leachable NDBA and other small molecule nitrosamines in infusion bags by an ultra-s


    Event Spekaer: Dujuan Lu Dujuan Lu
  • Credits
  • 6 Contact Hours
  • PREREQUISITES

    Virtual webinars. You can register for our webinar by sending a signed registration form. The confirmation and invoice will be sent to you within one working day. The payment date is 10 days from the invoice date. If the reservation is made within 10 days of the start date of the webinar, payment should be made immediately. Payment can be made by bank transfer or credit card. Uventia is not responsible for any additional bank charges related to payment. We require full payment of the invoice amount before the webinar date. Two days before the webinar starts, you will receive instructions for joining. Each webinar subscription is for personal use only and cannot be shared.

    TARGET AUDIENCE

    Medical Lab SpecialistHealthcare ManagementVPs, GMs, Directors, Heads and ManagersRegulatory affairsPrimary Packaging material designersMedical AffairsClinical Laboratory SciencesLaboratory Medicine Specialists

    SPECIALITIES

    Pharmacology

    REFUND, CANCELLATION POLICY & DISCLAIMER

    Virtual webinars. Cancellation is required in writing only. If you cancel within 24 hours after registering for the webinar, the registration fee can be refunded in full. Cancellation after this time will incur the full registration fee. If recording is possible, registered representatives who cannot access the live webinar will receive the recording after the webinar or presentation slides. Non-attendance to the live webinar will still be charged the full registration fee. If payment is received and recording access is provided, there will be no refund. The delegate pass cannot be transferred to another webinar and no substitutions possible.

    DISCLAIMER

    Virtual Webinars. If we need to change the webinar program, postpone the webinar, cancel or replace the speaker (for example, the speaker suddenly falls ill), the reimbursement of the registration fee is not possible. However, if the event was cancelled, the delegate has the right to refund the registration fee.