Extractables & Leachables West 2023

Ensuring Quality, Safety, Suitability and Regulatory Compliance for Drugs, Biologics and Medical Devices

November 2-3, 2023, La Jolla, CA

Meet Our 2023 Speakers

Katie Grayson
Katie Grayson
General Manager
EKG Life Sciences/Infinity Labs
Marine Lepoutre
Marine Lepoutre
Global Subject Matter Expert
GSK
Ping Wang
Ping Wang
Director
Johnson & Johnson
Dennis Jenke
Dennis Jenke
Founder & CSO
Triad Scientific Solutions
David Saylor
David Saylor
Materials Scientist
FDA
Sandi Schaible
Sandi Schaible
Senior Director
WuXi AppTec
Sherry Parker
Sherry Parker
Principal
SParker Toxicology Consulting
Etienne Michel
Etienne Michel
Senior Manager-Global QA
GSK
Ronald Brown
Ronald Brown
Principal
Risk Science Consortium
Kevin Rowland
Kevin Rowland
Director of R&D
RQM Plus
Roberto Menzel
Roberto Menzel
Laboratory Supervisor E&L
Sartorius Stedim Biotech
Ted Heise
Ted Heise
VP, Regulatory & Clinical
MED Institute
Michael Ruberto
Michael Ruberto
Owner & Principal
Material Needs Consulting
Dujuan Lu
Dujuan Lu
E&L Manager/Global Leader
SGS
Eric Hill
Eric Hill
Senior Director
Boston Analytical
Will Parker
Will Parker
Director, E&L
Boston Analytical
György Vas
György Vas
Business Technical Scientific Liaison
Intertek
Michael Eakins
Michael Eakins
Founder & Principal
Eakins & Associates
Nicole Soucy
Nicole Soucy
Director, Global Toxicology & Biocompatibility
Boston Scientific
Emma Leishman
Emma Leishman
Manager, Advanced Analytics
Element Materials Technology
Jiaru Zhang
Jiaru Zhang
Principal Scientist
Gradient
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Extractables & Leachables West 2023

November 2 November 3

“This continues to be one of the premier conferences on E&L!”

~ Senior Principal Scientist & Group Leader, Bausch + Lomb

Event Summary

This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. We will focus closely on the keys to satisfying recent revisions to several applicable USP chapters, FDA guidances & other international regulatory requirements for best practices in materials and chemistry characterization for drugs, biologics, delivery systems, and primary & secondary packaging.

Set your brand apart by sponsoring Extractables & Leachables West 2023!

Contact Kim:

217-721-5774

khubbard@pharmaedresources.com

Why Attend:

  • Two full days of presentations, panel discussions, and networking
  • The industry’s top experts share their knowledge and lessons learned
  • Learn what you need to know to meet regulatory expectations for E/Ls in drug products, delivery systems, medical devices, and packaging
  • Focus on overcoming common analytical challenges in E/L study design
  • Gain insight into AET’s and uncertainty factors in E/L analysis
  • Explore E&L Assessment in Cell & Gene Therapies

What People Are Saying about Pharma Ed’s Extractables & Leachables Annual Summit!

“This continues to be one of the premier conferences on E&L!”
~ Senior Principal Scientist & Group Leader, Bausch + Lomb

“This is a valuable conference, with many expert speakers.”
~ Senior Manager, EMD Millipore

“I go to a lot of E/L conferences, and this was an excellent one.”
~ Senior Scientist, Boehringer Ingelheim

“I am new to the med device E/L scene, so I attended as a learning opportunity. I feel the conference was very informative and balanced various subject areas very well. I’ll definitely plan on attending again.”
~ Research Toxicologist, NSF International

“Great audience with good speakers. Would love to attend again.”
~  Senior Scientist, Pfizer

Pharma Ed’s Extractables & Leachables Summit is Sponsored by

Silver Sponsors

Event Sponsors

Intertek
EKG Labs
Datwyler
RQM
SGS
Boston Analytical
Safe Bridge consultants
WuXi AppTec logo
NAMSA
Aspen Reasearch
Primera
Ondrug Delivery
Triad

Illinois USA

2810 Robeson Park Drive
Champaign, IL 61822 United States
+ Google Map
217.721.5774
View Venue Website

PharmaED Resources

217.721.5774

View Organizer Website