Extractables and Leachables USA Conference

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width: 23%; margin-right: 2%; margin-bottom: 0.5em;" /> <img src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/quote bubbles/el-quote-box-thermo-fisher-scientific.jpg" style="float: left; width: 23%; margin-right: 2%; margin-bottom: 0.5em;" /> <img src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/quote bubbles/el-quote-box-abbvie.jpg" style="float: left; width: 23%; margin-right: 2%; margin-bottom: 0.5em;" /> <img src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/quote bubbles/el-quote-box-aspen.jpg" style="float: left; width: 23%; margin-right: 2%; margin-bottom: 0.5em;" /> <h2 style="clear: both; text-align: center;"><strong>The 2025 Agenda is Here!</strong></h2> <h3 style="text-align: center;"><b>BioNTech, Lhasa Limited, Nelson Labs Europe, and more are presenting. <br /> <a href="http://www.eandl-conference.com/extractables-and-leachables-usa/agenda?EventId=5836">View the full line up>>>></a></b></h3> <p>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.<br /> <br /> This year's program features:</p> <ul> <li><strong>20+ Presentations</strong></li> <li><strong>4+ Hours of Networking</strong></li> <li><strong>Expert Panels</strong></li> <li><strong>Device Manufacturer Perspective</strong></li> <li><strong>Regualtory Expectations & Studies</strong></li> <li><strong>13+ Speakers and Panelists</strong></li> </ul> <h2 style="text-align: center;"><a href="http://www.eandl-conference.com/extractables-and-leachables-usa/event-pricing"><u><strong>  Register today>>>>>>  </strong></u>     </a>              </h2> <p style="text-align: center;"><br /> 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.</p> <hr style="height:2px;border:none;color:#333;background-color:#333;" /><a href="https://www.eandl-conference.com/extractables-and-leachables-usa/sponsor-exhibit-information"> </a><br />   <table align="center" border="0" cellpadding="1" cellspacing="1" style="width: 1000px;"> <tbody> <tr> <td style="text-align: center;"><a href=" "><img alt="Extractables and Leachables Photo" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/pictures/34686332081_f05a2d2b88_w.jpg" /></a></td> <td style="text-align: center;"><a href=" "><img alt=" Extractables and Leachables Photo" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/pictures/33998129414_344627e555_w.jpg" /></a></td> <td style="text-align: center;"><a href=" "><img alt=" Extractables and Leachables Photo" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/pictures/34686332351_32e5ba9fc2_w.jpg" /></a></td> </tr> </tbody> </table> <a href="https://www.eandl-conference.com/extractables-and-leachables-usa/event-overview"> </a> <p style="text-align: center;"><a href=" https://www.eandl-conference.com/extractables-and-leachables-usa/photos-and-testimonials"><input onclick="window.location.href='https://www.eandl-conference.com/extractables-and-leachables-usa/photos-and-testimonials'" style="width: 350px; padding: 12px; cursor: pointer; -moz-box-shadow: 6px 6px 5px #999; font-weight: bold; background: #0e76bd; color: #ffffff; border-radius: 2px; border: 2px solid #000; font-size: 100%;" type="button" value="View Event Photos and Testimonials" /> </a></p> <hr style="height:2px;border:none;color:#333;background-color:#333;" /> </div> </div> <div id="Agenda" class="section max-width unpadded-top"> <div class="event-section-header"> <h3>2025 Agenda</h3> <a class="cta-button white" href="/extractables-and-leachables-usa/agenda?EventId=5836"> View Full Agenda </a> </div> <div class="agenda js-agenda"> <div class="agenda-day-selector js-agenda-day-selector"> <a data-day-id="19257" class="option active">DAY ONE: Tuesday, May 20, 2025</a> <a data-day-id="19258" class="option ">DAY TWO: Wednesday, May 21, 2025</a> </div> <div class="toggle-view-group"> <div data-day-id="19257" class="toggle-view js-agenda-day agenda-day active"> <div class="toggle-view-group agenda-timetable"> <div data-track-id="0" class="toggle-view agenda-track js-agenda-track active"> <div class="agenda-session"> <time dateTime="7:30am">7:30am</time> <div class="details"> <h5>Registration Opens</h5> </div> </div> <div class="agenda-session"> <time dateTime="8:30am">8:30am</time> <div class="details"> <h5>Session I: Implementation of Regulatory Expectations</h5> </div> </div> <div class="agenda-session"> <time dateTime="10:30am">10:30am</time> <div class="details"> <h5>Session II: Designing E&L Studies</h5> </div> </div> <div class="agenda-session"> <time dateTime="1:30pm">1:30pm</time> <div class="details"> <h5>Session III: Executing E&L Studies</h5> </div> </div> <div class="agenda-session"> <time dateTime="3:45pm">3:45pm</time> <div class="details"> <h5>Session IV: Toxicologically Assessing E&L Studies</h5> </div> </div> <div class="agenda-session"> <time dateTime="5:30pm">5:30pm</time> <div class="details"> <h5>Day 1 Concludes, Networking Reception</h5> </div> </div> </div> </div> </div> <div data-day-id="19258" class="toggle-view js-agenda-day agenda-day"> <div class="toggle-view-group agenda-timetable"> <div data-track-id="0" class="toggle-view agenda-track js-agenda-track active"> <div class="agenda-session"> <time dateTime="8:00am">8:00am</time> <div class="details"> <h5>Registration Opens</h5> </div> </div> <div class="agenda-session"> <time dateTime="8:30am">8:30am</time> <div class="details"> <h5>Sessions V: Medical Device Manufacturers Case Studies and Panel: The Trials and Tribulations of Chemical Characterization</h5> </div> </div> <div class="agenda-session"> <time dateTime="10:15am">10:15am</time> <div class="details"> <h5>Session VI: Emerging Topics in E&L</h5> </div> </div> <div class="agenda-session"> <time dateTime="1:30pm">1:30pm</time> <div class="details"> <h5>Session VII: Test Materials for Targeted Compounds</h5> </div> </div> <div class="agenda-session"> <time dateTime="3:45pm">3:45pm</time> <div class="details"> <h5>Closing Remarks </h5> </div> </div> </div> </div> </div> </div> </div> </div><div id="Speakers" class="section max-width unpadded-top"> <div class="event-section-header"> <h3>2025 Speakers</h3> <a class="cta-button white" href="/extractables-and-leachables-usa/speakers?EventId=5836"> View all 12 speakers </a> </div> <div class="vips speaker-vips"> <a class="speaker vip" data-modal-open="speaker-modal-4212"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/kaja-el-2024.jpg?ext=.jpg" alt="Ravi Kaja Ph.D. - USP" /> </div> <h4 class="vip-name">Ravi Kaja Ph.D.</h4> <h5 class="vip-title"> <span>Senior Principal Scientist</span> <span class="preposition">at</span> USP </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/usp-520-240.jpg?ext=.jpg" alt="USP" /> </span> </a> <a class="speaker vip" data-modal-open="speaker-modal-4880"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/bishop.jpg?ext=.jpg" alt="Diego Zulkiewicz Gomes - Lhasa Limited" /> </div> <h4 class="vip-name">Diego Zulkiewicz Gomes</h4> <h5 class="vip-title"> <span>Senior Global Alliances Manager</span> <span class="preposition">at</span> Lhasa Limited </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/lhasa-limited-520.jpg?ext=.jpg" alt="Lhasa Limited" /> </span> </a> <a class="speaker vip" data-modal-open="speaker-modal-494"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/dujuan.png?ext=.png" alt="Dujuan Lu, Ph.D. - SGS Health Sciences" /> </div> <h4 class="vip-name">Dujuan Lu, Ph.D.</h4> <h5 class="vip-title"> <span>Manager/Global Leader-E&L</span> <span class="preposition">at</span> SGS Health Sciences </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/sgs-520-240.jpg?ext=.jpg" alt="SGS Health Sciences" /> </span> </a> <a class="speaker vip" data-modal-open="speaker-modal-4127"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/sheri-namsa-el-2024.jpg?ext=.jpg" alt="Sheri Krajewski - NAMSA" /> </div> <h4 class="vip-name">Sheri Krajewski</h4> <h5 class="vip-title"> <span>Senior Global Product Marketing Manager, Biological Evaluation of Medical Devices</span> <span class="preposition">at</span> NAMSA </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/namsa-520-24.jpg?ext=.jpg" alt="NAMSA" /> </span> </a> <a class="speaker vip" data-modal-open="speaker-modal-4881"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/bishop.jpg?ext=.jpg" alt="Silvia De Paoli, Ph.D - Center for Biologics Evaluation and Review, FDA" /> </div> <h4 class="vip-name">Silvia De Paoli, Ph.D</h4> <h5 class="vip-title"> <span>Biological Reviewer</span> <span class="preposition">at</span> Center for Biologics Evaluation and Review, FDA </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/fda-dhhr-520.jpg?ext=.jpg" alt="Center for Biologics Evaluation and Review, FDA" /> </span> </a> <a class="speaker vip" data-modal-open="speaker-modal-4879"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/ikjot-sodhi.png?ext=.png" alt="Ikjot Sodhi - BioNTech SE" /> </div> <h4 class="vip-name">Ikjot Sodhi</h4> <h5 class="vip-title"> <span>CMC Associate Director</span> <span class="preposition">at</span> BioNTech SE </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/biontech-520-240.jpg?ext=.jpg" alt="BioNTech SE" /> </span> </a> <div class="speaker-modals"> <div id="speaker-modal-4212" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Ravi Kaja Ph.D.</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/kaja-el-2024.jpg?ext=.jpg" alt="Ravi Kaja Ph.D." /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/usp-520-240.jpg?ext=.jpg" alt="USP" /> </div> </div> <h5 class="vip-title"> <span>Senior Principal Scientist</span> <span class="preposition">at</span> USP </h5> <p> Experienced Professional in Formulation AR&D, E&L Studies, Glass Delamination Studies, Tech Ops. <br />Experience handling Project Management & Tech Transfer with a demonstrated history of working in the pharmaceuticals industry in Injectable and Ophthalmic formulations. Skilled in all Hyphenated techniques like LCMS, GCMS, ICP-MS besides HPLC, GC and Good Laboratory Practice (GLP), Method development and Validations, GMP, . Strong research professional with a Doctor of Philosophy (Ph.D.) focused in Analytical Chemistry from Acharya Nagarjuna University, Guntur. </p> </div> </div> </div> <div id="speaker-modal-4880" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Diego Zulkiewicz Gomes</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/bishop.jpg?ext=.jpg" alt="Diego Zulkiewicz Gomes" /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/lhasa-limited-520.jpg?ext=.jpg" alt="Lhasa Limited" /> </div> </div> <h5 class="vip-title"> <span>Senior Global Alliances Manager</span> <span class="preposition">at</span> Lhasa Limited </h5> <p> Coming Soon </p> </div> </div> </div> <div id="speaker-modal-494" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Dujuan Lu, Ph.D.</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/dujuan.png?ext=.png" alt="Dujuan Lu, Ph.D." /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/sgs-520-240.jpg?ext=.jpg" alt="SGS Health Sciences" /> </div> </div> <h5 class="vip-title"> <span>Manager/Global Leader-E&L</span> <span class="preposition">at</span> SGS Health Sciences </h5> <p> Dr. Dujuan Lu serves as the manager for the extractables and leachables (E&L) team at the SGS Fairfield New Jersey facility as well as the global leader amongst the three centers of excellence for E&L testing. Before joining SGS, she worked at Fresenius Kabi as a research scientist, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has extensive CRO and pharmaceutical/medical device industry experience with more than 500 E&L projects on a broad range of packaging systems, including process materials, pharmaceutical finished packaging, and medical devices. As a subject matter expert in the E&L field, she is frequently presenting at various conferences as invited speakers and technical session chairs. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list. <br />Dr. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and BS in chemistry from Nanjing University. She has authored more than 15 high-impart journal publications with more than 300 citations. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science. </p> </div> </div> </div> <div id="speaker-modal-4127" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Sheri Krajewski</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/sheri-namsa-el-2024.jpg?ext=.jpg" alt="Sheri Krajewski" /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/namsa-520-24.jpg?ext=.jpg" alt="NAMSA" /> </div> </div> <h5 class="vip-title"> <span>Senior Global Product Marketing Manager, Biological Evaluation of Medical Devices</span> <span class="preposition">at</span> NAMSA </h5> <p> Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska. </p> </div> </div> </div> <div id="speaker-modal-4881" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Silvia De Paoli, Ph.D</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/bishop.jpg?ext=.jpg" alt="Silvia De Paoli, Ph.D" /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/fda-dhhr-520.jpg?ext=.jpg" alt="Center for Biologics Evaluation and Review, FDA" /> </div> </div> <h5 class="vip-title"> <span>Biological Reviewer</span> <span class="preposition">at</span> Center for Biologics Evaluation and Review, FDA </h5> <p> Dr. De Paoli, an experienced biological reviewer at the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER), conducts toxicological risk assessments of extractables and leachables from medical devices, including those regulated as container closure systems designated as large volume parenteral (LVP) containers, playing a crucial role in ensuring the safety and efficacy of products that impact public health. </p> </div> </div> </div> <div id="speaker-modal-4879" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Ikjot Sodhi</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/ikjot-sodhi.png?ext=.png" alt="Ikjot Sodhi" /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/biontech-520-240.jpg?ext=.jpg" alt="BioNTech SE" /> </div> </div> <h5 class="vip-title"> <span>CMC Associate Director</span> <span class="preposition">at</span> BioNTech SE </h5> <p> Ikjot Sodhi is working as subject matter expert (SME) for Extractables & Leachables at BioNTech SE, Germany. Within the organization, she also supports the material qualification process in decision making through advising on E&L related quality standards, qualification criteria, certifications from suppliers, among other roles. With the support of her team, she is currently leading the responsibility to implement the E&L relevant upcoming regulatory requirements at BioNTech SE. Previously, she worked at Fresenius Kabi Oncology Ltd., Gurgaon, India in dual role of formulation scientist and E&L SME. </p> </div> </div> </div> </div> </div> </div> <div id="Sponsors" class="section max-width unpadded-top"> <div class="event-section-header"> <h3>2025 Sponsors</h3> </div> <div class="company-list"> <a data-modal-open="sponsor-modal-5887" class="company-item" target="_blank" rel="noopener"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/element-(vr-analytical)-520-240.jpg?ext=.jpg" alt="Element Materials Technology" /> </div> </a> <a data-modal-open="sponsor-modal-14872" class="company-item" target="_blank" rel="noopener"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/namsa-520-240.jpg?ext=.jpg" alt="Namsa" /> </div> </a> <a data-modal-open="sponsor-modal-5883" class="company-item" target="_blank" rel="noopener"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/nelson-labs-520-240-030122.jpg?ext=.jpg" alt="Nelson Labs" /> </div> </a> <a data-modal-open="sponsor-modal-7895" class="company-item" target="_blank" rel="noopener"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/smithers-520-240.jpg?ext=.jpg" alt="Smithers" /> </div> </a> <a data-modal-open="sponsor-modal-19158" class="company-item" target="_blank" rel="noopener"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/solvias-520.jpg?ext=.jpg" alt="Solvias" /> </div> </a> <div class="company-list-modals"> <div id="sponsor-modal-5887" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Element Materials Technology</h4> <div class="modal-body no-footer"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/element-(vr-analytical)-520-240.jpg?ext=.jpg" alt="Element Materials Technology" /> </div> <a href="https://www.element.com/" target="_blank" rel="noopener">https://www.element.com/</a> <div class="modal-copy-container"> <p>Element is little more than a decade old, but can trace its origins back to 1827. With roots based in industrial testing and measurement  in the Victorian era, Element businesses have been involved in materials and product testing that gave the world the Model T ford, put Concorde into the skies and has helped keep Venice afloat. </p> <p>Element was formed in 2010, after a management buy-out of the testing division of the Netherlands-based Stork Engineering Group, backed by 3i Group plc. Starting with 860 people in 27 laboratories, the Group has grown dramatically in the last ten years, as many organisations have moved their testing requirements to specialist providers.</p> </div> </div> </div> </div> <div id="sponsor-modal-14872" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Namsa</h4> <div class="modal-body no-footer"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/namsa-520-240.jpg?ext=.jpg" alt="Namsa" /> </div> <a href="https://namsa.com/" target="_blank" rel="noopener">https://namsa.com/</a> <div class="modal-copy-container"> The World’s Leading MedTech CRO Offering Global End-to-End Development Services.<br />  <br /> Driven by our regulatory expertise and in-depth therapeutic knowledge, NAMSA has assisted thousands of MedTech Sponsors make a positive impact to healthcare since 1967. Today, our team of global Associates delivers market-leading Contract Research Organization (CRO) services to Clients in all major markets of the world. NAMSA provides unparalleled medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction and commercialization. From concept to post-market, we are proud to fully support Clients through the delivery of exceptional outcomes throughout every stage of the MedTech development continuum. </div> </div> </div> </div> <div id="sponsor-modal-5883" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Nelson Labs</h4> <div class="modal-body no-footer"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/nelson-labs-520-240-030122.jpg?ext=.jpg" alt="Nelson Labs" /> </div> <a href="https://www.nelsonlabs.com/" target="_blank" rel="noopener">https://www.nelsonlabs.com/</a> <div class="modal-copy-container"> <p><strong>Why Choose Nelson Laboratories</strong><br /> <br /> Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it’s our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.<br /> Companies choose Nelson Laboratories for our:</p> <ul> <li>Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.</li> <li>Customer-centric culture. We take the time to understand your vision. Your goals become our goals.</li> <li>Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.</li> <li>Metric-driven testing processes. We're our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turn-around time, and testing accuracy.</li> <li>Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.</li> </ul> <p>See how we can help you mitigate risk, be first to market, and succeed with your customers.</p> </div> </div> </div> </div> <div id="sponsor-modal-7895" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Smithers</h4> <div class="modal-body no-footer"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/smithers-520-240.jpg?ext=.jpg" alt="Smithers" /> </div> <a href="https://www.smithers.com/industries/life-science/medical-device/chemical-analysis/extractables-and-leachables" target="_blank" rel="noopener">https://www.smithers.com/industries/life-science/medical-device/chemical-analysis/extractables-and-leachables</a> <div class="modal-copy-container"> Smithers offers a range of testing services for the medical and pharmaceutical industries, helping clients demonstrate compliance to specifications set by the<br /> FDA, EMA, USP, ASTM, and ISO. Our services include: <ul> <li>Pharmaceutical and Medical Device Extractables & Leachables analysis</li> <li>Drug Delivery Device and Accessories Testing</li> <li>Healthcare Product and Packaging Validation</li> <li>Support Demonstrating Regulatory Compliance</li> <li>Materials Selection, Characterization and Testing</li> </ul> COMMON CONTAINER AND DEVICE PLATFORMS <ul> <li>Closure Technologies and Accessories (Pre-fillable Syringes, Cartridges, Vials, Caps, Stoppers, Plunger Stoppers, PFS Back-stops, Needle Safety Accessories, Needles)</li> <li>Finished Handheld Injectors (Auto-injectors; Pen Injectors, Prefilled Syringes, Safety PFS, etc.)</li> <li>Needle-Free Injectors</li> <li>On-body Injectors (Patch Pumps, Large Volume Injectors)</li> <li>Specialty Injectors (Microneedles)</li> </ul> </div> </div> </div> </div> <div id="sponsor-modal-19158" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Solvias</h4> <div class="modal-body no-footer"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos%20and%20photos%20of%20people/solvias-520.jpg?ext=.jpg" alt="Solvias" /> </div> <a href="https://www.solvias.com/" target="_blank" rel="noopener">https://www.solvias.com/</a> <div class="modal-copy-container"> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="color:black">Solvias helps innovative companies advance their path to commercialization with CMC analytical solutions powered by deep scientific expertise and a relentless focus on our customers’ success. With years of expertise in small molecules, biologics and cell and gene therapies, our talented subject matter experts have the know-how, creativity, and tenacity to solve even the most complex analytical challenges.  Solvias offers comprehensive solutions from raw materials to drug products to final release testing as well as API development and manufacturing for small molecules. Customers have a single, trusted analytical partner for their entire development journey.</span></span></span> </div> </div> </div> </div> </div> </div> </div> <div id="AdvisoryBoard" class="section max-width unpadded-top"> <div class="event-section-header"> <h3>Advisory Board</h3> <a class="cta-button white" href="/extractables-and-leachables-usa/advisory-board?EventId=5836"> View all 8 board members </a> </div> <div class="vips board-member-vips"> <a class="board-member vip" data-modal-open="board-member-modal-479"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/dennis-jenke.png?ext=.png" alt="Dennis Jenke - Triad Scientific Solutions" /> </div> <h4 class="vip-name">Dennis Jenke</h4> <h5 class="vip-title"> <span>Chief Executive Scientist</span> <span class="preposition">at</span> Triad Scientific Solutions </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/triad-520-240.jpg?ext=.jpg" alt="Triad Scientific Solutions" /> </span> </a> <a class="board-member vip" data-modal-open="board-member-modal-483"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/cheryl-stults.jpg?ext=.jpg" alt="Dr. Cheryl Stults - C&M Technical Consulting" /> </div> <h4 class="vip-name">Dr. Cheryl Stults</h4> <h5 class="vip-title"> <span>Principal</span> <span class="preposition">at</span> C&M Technical Consulting </h5> </a> <a class="board-member vip" data-modal-open="board-member-modal-484"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/carsten-worsoe.png?ext=.png" alt="Carsten Worsøe - Novo Nordisk" /> </div> <h4 class="vip-name">Carsten Worsøe</h4> <h5 class="vip-title"> <span>Principal Scientist Extractables and Leachables</span> <span class="preposition">at</span> Novo Nordisk </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/novo-nordisk-520-240.jpg?ext=.jpg" alt="Novo Nordisk" /> </span> </a> <a class="board-member vip" data-modal-open="board-member-modal-1085"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-europe/ron-brown.png?ext=.png" alt="Ron Brown - Risk Science Consortium, LLC & US FDA (Retired)" /> </div> <h4 class="vip-name">Ron Brown</h4> <h5 class="vip-title"> <span>Toxicologist</span> <span class="preposition">at</span> Risk Science Consortium, LLC & US FDA (Retired) </h5> </a> <a class="board-member vip" data-modal-open="board-member-modal-943"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-europe/patricia-parris.png?ext=.png" alt="Patricia Parris - Pfizer" /> </div> <h4 class="vip-name">Patricia Parris</h4> <h5 class="vip-title"> <span>Global Risk Assessment Services Toxicologist, Drug Safety Research & Development</span> <span class="preposition">at</span> Pfizer </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-europe/pfizer-logo.png?ext=.png" alt="Pfizer" /> </span> </a> <a class="board-member vip" data-modal-open="board-member-modal-482"> <div class="vip-image image-container"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/roger-pearson-260.jpg?ext=.jpg" alt="Dr. Roger Pearson - Aspen Research Corporation" /> </div> <h4 class="vip-name">Dr. Roger Pearson</h4> <h5 class="vip-title"> <span>President of Analytical Services</span> <span class="preposition">at</span> Aspen Research Corporation </h5> <span class="image-container contain company-logo"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/aspen-research-520-240.jpg?ext=.jpg" alt="Aspen Research Corporation" /> </span> </a> <div class="board-member-modals"> <div id="board-member-modal-479" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Dennis Jenke</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/dennis-jenke.png?ext=.png" alt="Dennis Jenke" /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/triad-520-240.jpg?ext=.jpg" alt="Triad Scientific Solutions" /> </div> </div> <h5 class="vip-title"> <span>Chief Executive Scientist</span> <span class="preposition">at</span> Triad Scientific Solutions </h5> <p> Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter Healthcare Corporation where for more than four decades he lead a team whose primary responsibility includes the assessment of material/product compatibility, specifically with respect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/leachables and product ingredient binding) </p> </div> </div> </div> <div id="board-member-modal-483" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Dr. Cheryl Stults</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/cheryl-stults.jpg?ext=.jpg" alt="Dr. Cheryl Stults" /> </div> </div> <h5 class="vip-title"> <span>Principal</span> <span class="preposition">at</span> C&M Technical Consulting </h5> <p> Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters. </p> </div> </div> </div> <div id="board-member-modal-484" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Carsten Worsøe</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/carsten-worsoe.png?ext=.png" alt="Carsten Worsøe" /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/novo-nordisk-520-240.jpg?ext=.jpg" alt="Novo Nordisk" /> </div> </div> <h5 class="vip-title"> <span>Principal Scientist Extractables and Leachables</span> <span class="preposition">at</span> Novo Nordisk </h5> <p> Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects. </p> </div> </div> </div> <div id="board-member-modal-1085" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Ron Brown</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-europe/ron-brown.png?ext=.png" alt="Ron Brown" /> </div> </div> <h5 class="vip-title"> <span>Toxicologist</span> <span class="preposition">at</span> Risk Science Consortium, LLC & US FDA (Retired) </h5> <p> Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis. </p> </div> </div> </div> <div id="board-member-modal-943" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Patricia Parris</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-europe/patricia-parris.png?ext=.png" alt="Patricia Parris" /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-europe/pfizer-logo.png?ext=.png" alt="Pfizer" /> </div> </div> <h5 class="vip-title"> <span>Global Risk Assessment Services Toxicologist, Drug Safety Research & Development</span> <span class="preposition">at</span> Pfizer </h5> <p> Trish joined Pfizer in February 2020 as a Global Risk Assessment Services Toxicologist in Drug Safety R&D. Trish has a background in Genetic Toxicology and over the last 12 years has built expertise in mutagenic impurity, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in ICH M7 working group to develop Appendix 3 and co-authored hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation Sub-teams and is an active member of the EFPIA working group to support ICHQ3E. </p> </div> </div> </div> <div id="board-member-modal-482" class="modal detail-modal" data-modal data-close-on-outside-click> <div class="modal-content"> <h4 class="modal-header">Dr. Roger Pearson</h4> <div class="modal-body no-footer"> <div class="images"> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/roger-pearson-260.jpg?ext=.jpg" alt="Dr. Roger Pearson" /> </div> <div class="image-container contain"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/logos and photos of people/aspen-research-520-240.jpg?ext=.jpg" alt="Aspen Research Corporation" /> </div> </div> <h5 class="vip-title"> <span>President of Analytical Services</span> <span class="preposition">at</span> Aspen Research Corporation </h5> <p> Dr. Pearson received his B.S. in Chemistry from Montana State University and his M.S. and Ph.D. in Environmental Chemistry from the University of Minnesota’s School of Public Health. Dr. Pearson joined Aspen Research in 1997 from a post-doctoral position at the University of Minnesota. His prior professional experience includes positions as a Research Chemist and Production Superintendent for Celanese Chemical Corporation. Dr. Pearson has extensive experience in gas chromatographic analysis of volatile and semi-volatile compounds, has coordinated many studies of off gassing phenomena at elevated process temperatures, and is an expert at coupling analytical results back to their process chemistry. He is an industry recognized expert in Extractables and Leachables techniques whose studies have been instrumental in assisting risk professionals in providing guidance for companies navigating in various regulatory arenas. </p> </div> </div> </div> </div> </div> </div> <div class="section max-width"> <div class="image-widget"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/website%20images/e-l-smithers-expertise-v2.jpg" alt="e-l-smithers-expertise-V2" /> </div> <div> </div><div> <p style="text-align: center;"><input onclick="window.location.href='https://www.smithers.com/industries/life-science/medical-device/chemical-analysis/extractables-and-leachables'" style="width: 350px; padding: 12px; cursor: pointer; -moz-box-shadow: 6px 6px 5px #999; font-weight: bold; background: #006738; color: #ffffff; border-radius: 3px; border: 0px solid #999; font-size: 100%;" type="button" value="Meet Our Experts" /> </p></div> <div>     <hr />     </div> <div> </div><div> <h3 class="underlined">Learn More About Smithers' Events</h3> </div> <div> <iframe width="900" height="450" src="https://www.youtube.com/embed/iteyDbuOlc0"></iframe></div> <div> </div><div>     <hr />     </div> <div> </div><div class="row margins"> <div> <div class="image-widget"> <a href="https://www.linkedin.com/groups/3661926/"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/widgets/join-the-linkedin-community-icon-copy.jpg" alt="join-the-linkedin-community-icon-copy" /> </a> </div> </div> <div> <div class="image-widget"> <a href="https://www.eandl-conference.com/extractables-and-leachables-usa/join-the-mailing-list"> <img loading="lazy" src="https://media-cdn.smithers.com/mediacontainer/medialibraries/extractablesandleachables/e-l-usa/widgets/mailing-list-icon-copy.jpg" alt="MAILING-LIST-ICON-copy" /> </a> </div> </div> <div> </div> </div> <div>     <hr />     </div> <div> </div> </div> </div> <footer class="footer"> <ul> <li > <a href=https://www.smithers.com> © Smithers 2025 </a> </li> <li > <a > Contact us </a> </li> <li > <a href=https://www.smithers.com/policies/privacy-policy> Privacy Policy </a> </li> <li > <a > +86 (0)512 6253 5582 </a> </li> <li > <a > +44 (0) 1372 802000 </a> </li> <li > <a > +1 330 762 7441 </a> </li> </ul> </footer> <div id="cookie-banner-modal" class="modal open" data-modal> <div class="modal-content"> <form name="cookie-consent-form" action="/cookiepopup/setallowcookies" method="POST" class="js-validated-form" data-ajax novalidate> <h1 class="modal-header"> This Site Uses Cookies </h1> <div class="modal-body"> <p> Our site uses cookies so that we can remember you and understand how you use our site. 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