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  • Extractables & Leachables Europe
  • Extractables and Leachables USA
  • Extractables & Leachables Asia

Extractables and Leachables USA

Tuesday May 20- Wednesday May 21, 2025
Alexandria, VA


The 2025 Agenda is Here!

BioNTech, Lhasa Limited, Nelson Labs Europe, and more are presenting. 
View the full line up>>>>

Since 2006, Smithers Extractables & Leachables USA conference has been supporting the advancements in the E&L industry while keeping the industry informed on new regulations and testing protocols. This event assembles E&L experts to discuss the latest updates on regulations, best practices, compliance, case studies, biocompatibility, and more. Attendees network, build beneficial relationships, and hear diverse perspectives on issues facing the E&L industry both domestically and globally.

This year's program features:

  • 20+ Presentations
  • 4+ Hours of Networking
  • Expert Panels
  • Device Manufacturer Perspective
  • Regualtory Expectations & Studies
  • 13+ Speakers and Panelists

  Register today>>>>>>                     


Smithers Medical Device Testing is a leading authority for extractables and leachables studies, with experts who have a proven track record of developing and delivering comprehensive E&L test plans. The partnership between Smithers E&L laboratories and events combines expert technical knowledge and market intelligence on emerging needs from which the whole industry benefits.



 
Extractables and Leachables Photo  Extractables and Leachables Photo  Extractables and Leachables Photo


2025 Agenda

View Full Agenda
Registration Opens
Session I: Implementation of Regulatory Expectations
Session II: Designing E&L Studies
Session III: Executing E&L Studies
Session IV: Toxicologically Assessing E&L Studies
Day 1 Concludes, Networking Reception
Registration Opens
Sessions V: Medical Device Manufacturers Case Studies and Panel: The Trials and Tribulations of Chemical Characterization
Session VI: Emerging Topics in E&L
Session VII: Test Materials for Targeted Compounds
Closing Remarks
Ravi Kaja Ph.D. - USP

Ravi Kaja Ph.D.

Senior Principal Scientist at USP
Diego Zulkiewicz Gomes - Lhasa Limited

Diego Zulkiewicz Gomes

Senior Global Alliances Manager at Lhasa Limited
Dujuan Lu, Ph.D. - SGS Health Sciences

Dujuan Lu, Ph.D.

Manager/Global Leader-E&L at SGS Health Sciences
Sheri Krajewski - NAMSA

Sheri Krajewski

Senior Global Product Marketing Manager, Biological Evaluation of Medical Devices at NAMSA
Silvia De Paoli, Ph.D - Center for Biologics Evaluation and Review, FDA

Silvia De Paoli, Ph.D

Biological Reviewer at Center for Biologics Evaluation and Review, FDA
Ikjot Sodhi - BioNTech SE

Ikjot Sodhi

CMC Associate Director at BioNTech SE

2025 Sponsors

Element Materials Technology
Namsa
Nelson Labs
Smithers
Solvias
Dennis Jenke - Triad Scientific Solutions

Dennis Jenke

Chief Executive Scientist at Triad Scientific Solutions
Dr. Cheryl Stults - C&M Technical Consulting

Dr. Cheryl Stults

Principal at C&M Technical Consulting
Carsten Worsøe - Novo Nordisk

Carsten Worsøe

Principal Scientist Extractables and Leachables at Novo Nordisk
Ron Brown - Risk Science Consortium, LLC & US FDA (Retired)

Ron Brown

Toxicologist at Risk Science Consortium, LLC & US FDA (Retired)
Patricia Parris - Pfizer

Patricia Parris

Global Risk Assessment Services Toxicologist, Drug Safety Research & Development at Pfizer
Dr. Roger Pearson - Aspen Research Corporation

Dr. Roger Pearson

President of Analytical Services at Aspen Research Corporation
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