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

Extractables and Leachables USA 2024

Tuesday, May 21 –Wednesday, May 22, 2024
Bethesda, MD


 

The 2024 Program has been Announced!

Featuring Speakers from the FDA, Baxter, West Pharmaceutical, and More

View the Agenda >>

Since 2006, Smithers Extractables & Leachables USA conference has been supporting the advancements in the E&L industry while keeping the industry informed and up to date on new regulations and testing protocols. This event offers the industry a unique opportunity for E&L experts to gather and 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 in both the US and globally, delivering high level insight into the market and global landscape. Join The Mailing List to get the latest updates!

                                       


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, insight into emerging needs, and market intelligence into a collaboration from which the whole industry benefits.



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


2024 Agenda

View Full Agenda
Registration Opens
Session I: Digital Transformation in Pharma and Potential Impact of the Assessment of E&L Compounds
Session II: Challenges Associated with the Chemical Characterization for Medical Devices
Session III: Medical Device Manufacturers Case Studies and Panel: The Trials and Tribulations of Chemical Characterization
Session IV: Pharma and CRO Collaboration
Networking Reception
Registration Opens
Session V: Update on Standards & Regulations
Session VI: Practical Application of Approaches to Assessment Safety of E&L Compounds: Part I
Session VII: Practical Application of Approaches to Assessment Safety of E&L Compounds: Part II
Closing Remarks
Carsten Worsøe - Novo Nordisk

Carsten Worsøe

Principal Scientist Extractables and Leachables at Novo Nordisk
Dr. Jan Baeten  - Nelson Labs

Dr. Jan Baeten

Sr. Scientist – Technical Advisor at Nelson Labs
Jennifer Ator	 - ToxServices LLC

Jennifer Ator

Principal Toxicologist at ToxServices LLC
Sheri Krajewski - NAMSA

Sheri Krajewski

Senior Global Product Marketing Manager, Biological Evaluation of Medical Devices at NAMSA
Sandi Schaible - WuXi AppTec Medical Device Testing

Sandi Schaible

Senior Director, Analytical Chemistry and Regulatory Toxicology at WuXi AppTec Medical Device Testing
Jianfeng Hong - Fresenius Kabi USA

Jianfeng Hong

Sr. Research Scientist/ E & L Chemistry Lab Manager at Fresenius Kabi USA

2024 Sponsors

View all 9 sponsors
Aspen Research
Catalent
Intertek
Labcorp
Namsa
PPD®
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
Nick Morley - Element Materials Technology

Nick Morley

Principal Scientist at Element Materials Technology
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
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