9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit

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Genotoxic, Nitrosamine, & Beyond Summit</h1> <div class="info"> <ul> <li class="info__time"> <span class="info__cols"> <span class="info__col"> 9th – 10th <small>April 2025</small> </span> </span> </li> <li class="info__state"> <span class="info__flag" style="background-image: url(/files/2019/10/a807cea53fea3e6b147e2214d8a24db1.png)"> Austria flag </span> Austria <small>Vienna & Online</small> </li> <li class="info__address"> Novotel Wien Hauptbahnhof <small>Canettistraße 6, 1100 Wien</small> </li> </ul> <div class="info__links"> <a class="btn btn--w btn--paddingS" target="_blank" href="https://www.google.com/maps/place/Novotel+Wien+Hauptbahnhof/@48.1854379,16.3789543,18z/data=!4m11!3m10!1s0x476da9d7643e8a33:0xda52b70b9c4f2ed0!5m4!1s2025-04-08!2i2!4m1!1i2!8m2!3d48.1856743!4d16.379164!16s%2Fg%2F11d_2n6mj_?authuser=0&entry=ttu&g_ep=EgoyMDI1MDEyMi4wIKXMDSoASAFQAw%3D%3D">VENUE ADDRESS</a> <a class="btn btn--w btn--mmt" href="https://www.novotel-wien-hauptbahnhof.com/">VENUE WEBSITE</a> </div> </div> <div class="edetail__perex"> <p style="text-align: justify;">The detection and control of nitrosamines and other genotoxic impurities (GTIs) have become critical concerns, necessitating a comprehensive and rational risk assessment strategy to ensure product safety and regulatory compliance.</p> <p style="text-align: justify;">Welcome to <strong>#VLgenotoxic 2025</strong>, where our focus intensifies on the urgent issues surrounding N-nitrosamines. As the industry grapples with evolving regulatory frameworks, toxicological uncertainties, and the technical challenges of impurity identification, this summit serves as a vital platform for exploring these pressing issues.</p> <p style="text-align: justify;">Mark your calendars for the <strong>9th Impurities: Genotoxic, Nitrosamine, & Beyond</strong> conference, taking place on April 09-10, 2025.</p> <a data-fancybox id="more" href="#description" class="edetail__readmore">Read more</a> </div> <div class="detail detail--only-content detail--fancybox" id="description"> <div class="detail__container"> <div class="detail__content"> <h2><strong>Navigating the Complexities of Pharmaceutical Impurities: Trends and Challenges at the 9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit </strong><strong>(#VLgenotoxic)</strong></h2> <p>The Valsartan recall, driven by the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in widely prescribed pharmaceuticals, has been a pivotal moment for the pharmaceutical industry. This incident has underscored several critical issues:</p> <ul> <li>The urgent need to investigate potential N-nitrosamine contamination and assess the associated mutagenic and carcinogenic risks to patients.</li> <li>A wave of drug withdrawals, recalls, and clinical trial delays affecting medications like ranitidine, nizatidine, metformin, rifampin/rifapentine, and varenicline.</li> <li>The necessity of developing a balanced risk-assessment strategy to avoid misjudging the risks related to nitrosamines in pharmaceutical products.</li> </ul> <p> </p> <p>The Valsartan incident has revealed key gaps in current pharmaceutical practices, including:</p> <ul> <li>The need for more stringent scrutiny from both the FDA and drug manufacturers concerning NMDA and NDEA impurities.</li> <li>Emerging strategies and revised acceptable intake (AI) thresholds for nitrosamine impurities.</li> <li>Incorporating nitrosamine formation risk assessments into pharmaceutical processes, from drug substances (DS) and drug products (DP) to drug product packaging (DPP).</li> <li>The importance of collaboration among pharmaceutical experts, researchers, academia, and toxicologists to advance knowledge and methodologies that will shape future regulations for controlling N-nitrosamines and other mutagenic impurities.</li> <li>Developing robust control strategies to minimize nitrosamine impurities, optimize manufacturing processes, and reduce carcinogenic risks to patients.</li> <li>The complex risk analysis requires the involvement of multiple stakeholders, including API manufacturers, excipient providers, primary packaging suppliers, and drug product manufacturers.</li> </ul> <p>At the <strong>#VLgenotoxic 2025 Summit</strong>, our discussions will extend beyond N-nitrosamines, focusing on:</p> <ul> <li>Crucial aspects of detecting and reporting genotoxic impurities in the pharmaceutical industry.</li> <li>The latest findings from ongoing investigations, addressing regulatory, toxicological, analytical, and pharmaceutical considerations related to genotoxic impurities (GTIs).</li> <li>The implementation and impact of ICH M7 guidelines, offering insights into hazard identification and risk assessment processes for GTIs.</li> <li>Preventing N-nitrosamine contamination in human medicines and exploring alternative strategies for initial risk evaluation and confirmatory testing of drug products and APIs.</li> <li>Recent advancements and future considerations regarding various pharmaceutical impurities, including genotoxic impurities, nitrosamines, elemental impurities, extractables, and leachables.</li> </ul> <p>The <strong>9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit</strong>, scheduled for April 09-10, 2025, will gather leading experts to share their knowledge on these critical topics.</p> <p> </p> <p>Attendees will benefit from keynote presentations, detailed case studies, interactive panel discussions, and Q&A sessions. Explore exhibition opportunities and forge valuable partnerships while gaining insights into advanced strategies and evolving perspectives on impurities, extractables, and leachables (E&L).</p> <p> </p> <p>Our comprehensive program will also feature technical training and workshops focusing on:</p> <ul> <li>Practical regulatory and toxicological considerations for the identification, monitoring, and control of mutagenic impurities (ICH M7).</li> <li>Lessons learned and critical issues related to the quality, safety, and efficacy of drug products.</li> <li>Addressing uncertainties and inconsistencies in nitrosamine safety assessments.</li> <li>Updates on regulatory requirements and perspectives on nitrosamines.</li> <li>The latest experiences and developments in E&L and elemental impurities (ICH Q3D).</li> </ul> <p>Participants at <strong>#VLgenotoxic 2025</strong> will receive a digital certificate of attendance.</p> <p> </p> <h2>Who Should Attend:</h2> <p>Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:</p> <p> </p> <ul> <li>Analytical Science</li> <li>Active Pharmaceutical Ingredient (API) Development</li> <li>Assay Development</li> <li>Biotherapeutics</li> <li>Carcinogenic Impurities</li> <li>Carcinogenicity</li> <li>Carcinogens</li> <li>Chemistry (Analytical, Organic, Medicinal, Protein)</li> <li>Chromatography</li> <li>Degradation Products</li> <li>DNA Reactive Impurities</li> <li>DNA Reactivity</li> <li>Drug Design</li> <li>Drug Development</li> <li>Drug Discovery</li> <li>Drug Safety</li> <li>Drug Substance</li> <li>Elemental Impurities</li> <li>Extractables & Leachables</li> <li>Formulation</li> <li>Genetic Toxicology</li> <li>Genotoxic Impurities (GTI)</li> <li>Genotoxicity</li> <li>Genotoxin</li> <li>GMP</li> <li>Good Laboratory Practice</li> <li>GRAs</li> <li>GTIs</li> <li>Impurities</li> <li>In Silico</li> <li>Finished Pharmaceutical Products (FPPs)</li> <li>Large Molecule</li> <li>LC-MS</li> <li>Mass Spectrometry</li> <li>Microscopy</li> <li>Mutagenic Impurities</li> <li>Mutagenicity</li> <li>Nanomaterials</li> <li>Nanoparticles</li> <li>New Modality</li> <li>N-nitrosamine Drug Substance-Related Impurities (NDSRIs)</li> <li>Oligonucleotide</li> <li>Organic Synthesis</li> <li>Particles</li> <li>Peptide</li> <li>Potential Genotoxic Impurities (PGTIs)</li> <li>Preclinical Drug Safety</li> <li>Process Chemistry</li> <li>Process-Related Impurities</li> <li>Product-Related Impurities</li> <li>Protein</li> <li>Purification</li> <li>Purge Factors</li> <li>Quality Assurance (QA)</li> <li>Quality By Design (QbD)</li> <li>Quality Control (QC)</li> <li>Regulatory</li> <li>R&D</li> <li>Safety Assessment</li> <li>Small Molecule</li> <li>Spectroscopy</li> <li>Total Daily Intake (TDI)</li> <li>Technology Transfer</li> <li>Threshold of Toxicological Concern (TTC)</li> <li>Toxicology</li> <li>Validation</li> </ul> <p> </p> </div> </div> </div> <div class="sale sale--mobile"> <h2>Register by 28th February </h2> <p>The Early Bird Offer expires in 10 days!</p> </div> <div class="edetail__links"> <a class="btn btn--g btn--paddingS" href="#brochure-form" data-fancybox id="more">REQUEST A BROCHURE</a> <a class="btn btn--w btn--paddingS" href="/en/9th-impurities-genotoxic-nitrosamine-beyond-summit/packages">REGISTER NOW</a> <a class="btn btn--w btn--paddingS" href="/en/9th-impurities-genotoxic-nitrosamine-beyond-summit/sponsorships">Become a sponsor</a> </div> <div class="detail detail--fancybox detail--form" id="brochure-form"> <div class="detail__container"> <h2 class="detail__title">REQUEST A BROCHURE</h2> <div class="detail__perex"> <p>To request an agenda for this Summit, please complete the details below. 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value="1" type="checkbox" /> <label for="BrochuresRequest_tos">I confirm that I have read and agreed to <a target="_blank" href="/en/terms-conditions">Terms & Conditions</a> and <a target="_blank" href="/en/privacy-policy">GDPR</a>.</label> <div class="form__error" id="BrochuresRequest_tos_em_" style="display:none"></div> </div> <input name="BrochuresRequest[www]" id="BrochuresRequest_www" type="hidden" /> <div class="form__error" id="BrochuresRequest_www_em_" style="display:none"></div> <div class="form__link"> <button class="btn btn--g btn--wtext btn--wide">Send</button> </div> </div> </form> </div> </div> </div> <div class="edetail__topic"> <h2>KEY PRACTICAL LEARNING POINTS</h2> <div class="elist elist--has-more"> <ul> <li>Essential strategies for ensuring compliance with ICH M7 and Q3D guidelines</li> <li>Effective management of DNA-reactive N-nitrosamine impurities to reduce carcinogenic risks</li> <li>Addressing uncertainties, resolving discrepancies, and leveraging insights on nitrosamine-related challenges</li> <li>Investigating innovative methods and technologies for identifying, monitoring, and controlling genotoxic impurities</li> <li>Enhancing risk assessments and reviewing guidelines for the safe qualification of impurities</li> <li>Identifying and addressing potential gaps in the detection and control of mutagenic impurities.</li> <li>Navigating CMC regulations concerning genotoxic impurities, avoiding common pitfalls, and understanding industry standards</li> <li>Comprehensive evaluation, testing, and control of impurities in pharmaceutical products, drug substances, APIs, and excipients</li> <li>In-depth analysis of extractables and leachables (E&L) to assess genotoxicity and ensure thorough safety evaluations</li> <li>Latest updates, future trends, and expert insights into analytical techniques, regulatory expectations, and toxicological science</li> </ul> <button class="elist__more"></button> </div> </div> </div> <div class="edetail__col"> <div class="sale sale--desktop"> <h2>Register by 28th February </h2> <p>The Early Bird Offer expires in 10 days!</p> </div> <div class="micsec micsec--nmt"> <div class="micsec__row"> <h2 class="micsec__title">Speakers</h2> <div class="micsec__buttons"> <a class="btn btn--w" data-fancybox="1" id="more" href="#all-speakers">Full board</a> <a class="btn btn--w" href="/en/speaking">Become a speaker</a> </div> </div> <div class="speakers slick"> <a class="speakers__item speakers__item--has-text" href="#486-dr-andrew-teasdale-uk" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2022/03/th_aefb07a2e109969f27cd7b1d203d2489.png)"></div> <h3 class="speakers__name">Dr. Andrew Teasdale, UK </h3> <h2 class="speakers__subtitle">Senior Principal Scientist / Head of Impurity Management & CMC Strategy</h2> </div> <div class="speakers__text"><h4><span>AstraZeneca</span></h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#492-dr-raphael-nudelman-il" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2020/05/th_132c58953f0e75325c774ede7d259701.png)"></div> <h3 class="speakers__name">Dr. Raphael Nudelman, IL </h3> <h2 class="speakers__subtitle">Senior Director of Impurity Expert, R&D Operations</h2> </div> <div class="speakers__text"><h4><span>Teva Pharmaceutical Industries Ltd. </span></h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3107-dr-lutz-mueller-ch" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2023/10/th_387bda3ad049d1051ea30e5e8661af11.png)"></div> <h3 class="speakers__name">Dr. Lutz Mueller, CH</h3> <h2 class="speakers__subtitle">Chair Translational Safety Committee Pharma Research and Early Development (pRED)</h2> </div> <div class="speakers__text"><h4>Hoffmann-La Roche</h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3335-julien-patoor-ch" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2024/10/th_49f29c30f6d7bc9de3b6470018432d1d.png)"></div> <h3 class="speakers__name">Julien Patoor, CH</h3> <h2 class="speakers__subtitle">Director Analytical Project Management | Technical R&D</h2> </div> <div class="speakers__text"><p><strong>Novartis Pharma AG</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3310-michelle-kenyon-us" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2024/09/th_53d85b678b3338c317cf23d9e7fcffd6.png)"></div> <h3 class="speakers__name">Michelle Kenyon, US</h3> <h2 class="speakers__subtitle">Research Fellow I Drug Safety Toxicology Impurity Risk Management</h2> </div> <div class="speakers__text"><p><strong>Pfizer</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3209-dr-mark-harrison-uk" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2024/03/th_170a6b54e76b2f2af2a059b5215edd05.png)"></div> <h3 class="speakers__name">Dr. Mark Harrison, UK</h3> <h2 class="speakers__subtitle">Associate Principal Scientist - Trace EWG</h2> </div> <div class="speakers__text"><p><strong>AstraZeneca</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3303-dr-mayur-mitra-us" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2024/09/th_922abb6f89b1b33d70234a6030f0fd47.png)"></div> <h3 class="speakers__name">Dr. Mayur Mitra, US</h3> <h2 class="speakers__subtitle">Distinguished Scientist and Director</h2> </div> <div class="speakers__text"><p><strong>Genentech</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3116-dr-rok-grahek-sl" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2023/11/th_38fd01f11abd83e52ab440859f06b670.png)"></div> <h3 class="speakers__name">Dr. Rok Grahek, SL</h3> <h2 class="speakers__subtitle">Department Head</h2> </div> <div class="speakers__text"><h4>SDC Slovenia, Lek d.d., Sandoz</h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#2654-dr-carla-landolfi-it" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2022/09/th_f82dcd1440f1f2f2eae63ec0326bb45b.png)"></div> <h3 class="speakers__name">Dr. Carla Landolfi, IT</h3> <h2 class="speakers__subtitle">European Registered Toxicologist (ERT) CEO - Toxicology Risk Assessor</h2> </div> <div class="speakers__text"><h4>ToxHub</h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#2716-dr-paulo-eliandro-da-silva-junior-br" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2022/09/th_8b81db3680985acd9eb99ac88b1b7756.png)"></div> <h3 class="speakers__name">Dr. Paulo Eliandro da Silva Junior, BR </h3> <h2 class="speakers__subtitle">Technical and Regulatory Director</h2> </div> <div class="speakers__text"><h4>INTEGRA CONSULTANCY</h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#496-dr-alexander-amberg-de" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2023/11/th_c71a6ee88899a881456da13b3fc6a682.png)"></div> <h3 class="speakers__name">Dr. Alexander Amberg, DE </h3> <h2 class="speakers__subtitle">Head of In Silico Toxicology / R&D Preclinical Safety FF </h2> </div> <div class="speakers__text"><h4>Sanofi Aventis Deutschland GmbH</h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#2019-dr-george-johnson-uk" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2020/05/th_c8f044bd02d66bcf7e8767374a9edde8.png)"></div> <h3 class="speakers__name">Dr. George Johnson, UK</h3> <h2 class="speakers__subtitle">Associate Professor</h2> </div> <div class="speakers__text"><h4><strong>Institute of Life Science at Swansea University</strong></h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3347-ricarda-c-leister-de" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2025/01/th_20d8921b32cd11dab15b52d13136e55a.png)"></div> <h3 class="speakers__name">Ricarda C. Leister, DE</h3> <h2 class="speakers__subtitle">Head of Research & Development</h2> </div> <div class="speakers__text"><p><strong>MEGGLE Excipients</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3210-dr-nathanael-page-uk" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2025/02/th_d1efd97df4d7b4dd83b33946c0590135.png)"></div> <h3 class="speakers__name">Dr. Nathanael Page, UK</h3> <h2 class="speakers__subtitle">Associate Scientific Director</h2> </div> <div class="speakers__text"><p><strong>Resolian</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> </div> </div> <div class="detail detail--fancybox" id="486-dr-andrew-teasdale-uk"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Andrew Teasdale, UK </h2> <h3 class="detail__subtitle">Senior Principal Scientist / Head of Impurity Management & CMC Strategy</h3> <div class="detail__perex"> <h4><span>AstraZeneca</span></h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2022/03/dr-andrew-teasdale-uk-150x150px-300dpi-new.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Andrew Teasdale, PhD, is a senior principal scientist in impurity management and external advocacy at AstraZeneca. Andrew has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role, he chairs AstraZeneca’s impurity advisory group. Andrew has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences. He has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE). Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™. He also published a book addressing genotoxic impurities, ‘Genotoxic Impurities Strategies for Identification and Control,’ (Wiley and Son) and is soon to publish as editor a book focussed on practical implementation of ICH quality guidelines.</p> </div> </div> </div> <div class="detail detail--fancybox" id="492-dr-raphael-nudelman-il"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Raphael Nudelman, IL </h2> <h3 class="detail__subtitle">Senior Director of Impurity Expert, R&D Operations</h3> <div class="detail__perex"> <h4><span>Teva Pharmaceutical Industries Ltd. </span></h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2020/02/5-dr-raphael-nudelman-il.png)"></div> </div> <div class="detail__content"> <p>Raphael (Raphy) Nudelman is a chemical toxicologist with over 20 years of industry experience. He holds a PhD in organic chemistry from the Weizmann Institute of Science and completed postdoctoral research at the US Air Force Research Lab and Duke University Medical Center. At Teva Pharmaceutical Industries, Raphy held various roles, including in the medicinal chemistry department, the patent department, the non-clinical safety department, and as the Impurity Expert of the company. His expertise spans impurity and excipient qualification in drug substances and drug products, with a recent focus on risk assessment of nitrosamine impurities in pharmaceuticals. Raphy retired from Teva in September 2024 and founded Nudelman ChemTox Consulting, where he continues to provide consulting services in the pharmaceutical impurity qualification field.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3107-dr-lutz-mueller-ch"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Lutz Mueller, CH</h2> <h3 class="detail__subtitle">Chair Translational Safety Committee Pharma Research and Early Development (pRED)</h3> <div class="detail__perex"> <h4>Hoffmann-La Roche</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/10/dr-lutz-mueller-ch-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Dr. Lutz Mueller started his career with moving into genetic toxicology in 1981 when starting to work on his Diploma in biology. This means that he has accrued in the meantime about 40 years of experience in safety assessment of medicines. From 1989 on, he has been the head of the department of Mutagenesis and Carcinogenesis at the Federal Institute for Drugs and Medical Devices in Berlin, Germany. In 2000, he moved into industry to create a group of entrepreneurs working on “In silico Safety and Metabolism” at Novartis in Basel. While at Novartis, he began to realize the power of working with project leader responsibilities in Oncology. In late 2004, he moved to F. Hoffmann-La Roche into the role of a toxicology project leader and has ever increased his area of expertise in toxicology and safety assessment ever since. Small molecules, antisense modalities, biologics and vector-based gene therapy products for new medicines for human disease, he has worked on them all. He has also served as liason between safety assessment and research at Roche for neuroscience, ophthalmology and rare diseases establishing and tightening the close relationships between research and development in drug discovery. While he has contributed at Roche to move many molecules into man and further along the clinical development phase even into approval, the big reward came in Mid 2020 with the approval for the world’s first small molecule mRNA splice modifier, risdiplam. He has been a major driving force behind the fast R&D process on this medicine named Evrysdi to help patients with spinal muscular atrophy. Lutz Mueller is currently chairing the corporate Translational Safety Committee of Roche’s Pharma Research and Early Development function. His internal and external reputation is evidently documented with the title of “distinguished scientist” and supported by his contribution to more than 100 peer reviewed publications and book chapters. Moreover, he left his mark in the international contribution in the ICH guideline process since 1991, the inception of the ICH process. Still today, he is representing EFPIA on ICH M7, the “mutagenic impurities” guideline. He also earned his reputation being a frequent presenter at international conferences.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3335-julien-patoor-ch"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Julien Patoor, CH</h2> <h3 class="detail__subtitle">Director Analytical Project Management | Technical R&D</h3> <div class="detail__perex"> <p><strong>Novartis Pharma AG</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/10/julien-patoor-ch-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p>Julien Patoor studied chemistry at the National College of Chemical Engineering of Mulhouse, France (ENSCMu) with a specialization in analytical chemistry. In 2004 he joined GlaxoSmithKline as analytical expert in chemical development, supporting the testing and definition of control strategy for the manufacture of active pharmaceutical ingredients. Since 2009, he works for Novartis and, in his current role, is leading a team responsible of driving the analytical development of late phase small molecule assets up to their registration and commercial launch. Julien has a keen interest in understanding DS and DP impurity profiles including fate mapping, trace analytics such as nitrosamines, genotoxic impurities and elemental impurities as well as the associated regulatory landscape.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3310-michelle-kenyon-us"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Michelle Kenyon, US</h2> <h3 class="detail__subtitle">Research Fellow I Drug Safety Toxicology Impurity Risk Management</h3> <div class="detail__perex"> <p><strong>Pfizer</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/09/michelle-kenyon-us-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p>Michelle Kenyon, MA, is a research fellow in the Toxicology Impurity Risk Management group at Pfizer. Michelle has over 30 years of experience in the pharmaceutical industry as a genetic toxicologist with a focus for more than 20 years on the risk assessment and management of impurities. She leads a toxicology team responsible for Pfizer’s in silico mutagenicity assessments and co-leads a cross functional team that establishes acceptable intakes for nitrosamines in the portfolio. Michelle also represents Drug Safety as the co-lead of a cross-discipline team at Pfizer that provides development and commercial teams advice on safety and quality aspects of impurity control. She has also developed expertise in extractable and leachable and contaminant risk. Michelle’s expertise is recognised externally where she has worked collaboratively in cross industry groups, including the International Consortium for Innovation and Quality (IQ) DruSafe Impurities workgroup and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Impurities Management Workgroup where she has respectively been co-leading and leading subgroups that have recently published manuscripts related to non-mutagenic impurity management. She is also a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3C Guideline for Residual Solvents expert work group. Michelle has authored more than 25 peer-reviewed manuscripts relating to various impurity topics.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3209-dr-mark-harrison-uk"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Mark Harrison, UK</h2> <h3 class="detail__subtitle">Associate Principal Scientist - Trace EWG</h3> <div class="detail__perex"> <p><strong>AstraZeneca</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/03/dr-mark-harrison-uk-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p>Mark Harrison, PhD, is an associate principal scientist in trace analysis and external advocacy at AstraZeneca. Mark has over 30 years’ experience in the pharmaceutical and biochemical industries as an analytical chemist working within trace analysis and mass spectrometry specialisms. He currently co-chairs the IQ nitrosamine analytical advisory group. Mark has published over 20 papers relating to trace analysis, mutagenic impurities, and other impurity-related matters and has also been a speaker at many international conferences. He is actively involved in industry expert groups, including the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), having previously co-chaired the latter’s nitrite working group. Mark recently contributed to the book published by Andy Teasdale addressing genotoxic impurities, ‘Genotoxic Impurities Strategies for Identification and Control’, (Wiley and Son).</p> </div> </div> </div> <div class="detail detail--fancybox" id="3303-dr-mayur-mitra-us"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Mayur Mitra, US</h2> <h3 class="detail__subtitle">Distinguished Scientist and Director</h3> <div class="detail__perex"> <p><strong>Genentech</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/09/dr-mayur-mitra-us-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p>Mayur Mitra is an American board-certified toxicologist and currently serves as a Distinguished Scientist - Toxicologist within Safety Assessment at Genentech Inc. As part of his role he serves as the Therapy Area Lead for Genentech’s Oncology portfolio and as a Cross-functional Drug Development Team Lead. Previously, Mayur was employed as a Toxicologist at Bristol-Myers Squibb. Mayur received a PhD in Toxicology from the University of Louisiana at Monroe and a postdoctoral fellowship at the Washington University School of Medicine in St. Louis. Mayur is well published and has authored 25+ peer reviewed articles and book chapters.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3116-dr-rok-grahek-sl"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Rok Grahek, SL</h2> <h3 class="detail__subtitle">Department Head</h3> <div class="detail__perex"> <h4>SDC Slovenia, Lek d.d., Sandoz</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/11/dr-rok-grahek-sl-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Rok Grahek received his BSc in chemistry and his PhD in science from the University of Ljubljana, Slovenia.</p> <p style="text-align: justify;">In 1986, Rok was employed in R&D in Lek Pharmaceuticals d.d. Slovenia.</p> <p style="text-align: justify;">As a researcher he started with GC and after a few years HPLC and MS became his main area of interest in connection with impurities in drugs. Trace analysis of impurities (genotoxic impurities, synthetic tracers, nitrosamines) with LC-MS and GC-MS is an important area of Rok’s research. For the past 25 years, Rok has been leading a group or researchers dealing mainly with impurity profiles, impurities isolation, identification, and trace analytics.</p> <p style="text-align: justify;">Rok is an author or co-author of nearly 40 patents and scientific papers and more than 50 scientific conference contributions.</p> </div> </div> </div> <div class="detail detail--fancybox" id="2654-dr-carla-landolfi-it"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Carla Landolfi, IT</h2> <h3 class="detail__subtitle">European Registered Toxicologist (ERT) CEO - Toxicology Risk Assessor</h3> <div class="detail__perex"> <h4>ToxHub</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2022/09/dr-carla-landolfi-it-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Dr. Carla Landolfi graduated in chemistry and pharmaceutical technology from Rome University. She has more than 20 years of experience in the toxicology field gained in the pharmaceutical industry, 10 of them as manager to the toxicology group. She's the main or co-author of several papers and posters, has published in peer-reviewed journals, and she's an invited speaker at international conferences as well as the founding editor of archives of clinical toxicology. In 2020, she founded the ToxHub, a consultancy company specialised in toxicological risk assessment and regulatory toxicology.</p> </div> </div> </div> <div class="detail detail--fancybox" id="2716-dr-paulo-eliandro-da-silva-junior-br"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Paulo Eliandro da Silva Junior, BR </h2> <h3 class="detail__subtitle">Technical and Regulatory Director</h3> <div class="detail__perex"> <h4>INTEGRA CONSULTANCY</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2022/09/dr-paulo-eliandro-da-silva-junior-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Dr. Paulo Eliandro da Silva Junior is a pharmacist-biochemist (USP) with a master's and PhD in medicinal chemistry, synthesis and drug discovery (FCFRP-USP, University of East Anglia – UEA, UK; Johannes Gutenberg University of Mainz – JGU, Germany). Paulo's experience in the pharmaceutical industry started in 2013 as a trainee at Novartis, Horsham, UK, in the global discovery chemistry department. After that Paulo worked mainly in regulatory affairs, quality audits, and drug product and drug substance development with focus on impurities control, including E&L, mutagenic impurities, such as nitrosamines, in his own consulting company, Integra Consultancy. Paulo also is a founder of another company, BIND, which is a startup for synthesis and characterisation of analytical standard for development processes, and teaches postgraduate courses that cover various pharmaceutical topics.</p> </div> </div> </div> <div class="detail detail--fancybox" id="496-dr-alexander-amberg-de"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Alexander Amberg, DE </h2> <h3 class="detail__subtitle">Head of In Silico Toxicology / R&D Preclinical Safety FF </h3> <div class="detail__perex"> <h4>Sanofi Aventis Deutschland GmbH</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/11/dr-alexander-amberg-de-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Alexander Amberg performed his doctoral studies at the department of toxicology and pharmacology at the University of Wuerzburg (Germany) and obtained his PhD in biochemical toxicology in 2000. In 2001, he joined the early and exploratory safety group of Sanofi, and in this position has been responsible for in silico/computational toxicology analysis globally at Sanofi. Since 2007, he has been registered as a European registered toxicologist (ERT) after getting his examination of Fachtoxikologe DGPT from the German Society of Toxicology. His major research interests are development of new in silico prediction models for different toxicity endpoints and data management of in-house data in combination with publicly available toxicity data, to support drug development in research and development. For this he is also a member of different internal expert advisory groups as well as external initiatives, like the IMI eTOX consortium (for toxicity data sharing and development of new expert systems for in silico toxicity prediction), the IMI SafeSciMET education program and others. With respect to genotoxic impurities (GTIs), he was actively involved in the preparation of the white paper for the use of in silico systems in the scope of ICH M7 and other publications regarding GTIs. Internally, he is member of the task force to support the in-house implementation of ICH M7.</p> </div> </div> </div> <div class="detail detail--fancybox" id="2019-dr-george-johnson-uk"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. George Johnson, UK</h2> <h3 class="detail__subtitle">Associate Professor</h3> <div class="detail__perex"> <h4><strong>Institute of Life Science at Swansea University</strong></h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2020/03/12-dr-george-johnson-uk-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">George Johnson is an associate professor of genetic toxicology at Swansea University. He has expertise in the quantitative use of genetic toxicity data for hazard and risk assessment purposes and has an interest in high content and multiplex in-vitro test systems. He currently has active roles in the HESI-GTTC, IWGT 2022, COM and EEMGS-EXCOM, and carries out teaching, research, and consultancy at Swansea.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3347-ricarda-c-leister-de"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Ricarda C. Leister, DE</h2> <h3 class="detail__subtitle">Head of Research & Development</h3> <div class="detail__perex"> <p><strong>MEGGLE Excipients</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2025/01/ricarda-c-leister-de-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p>With more than 20 years of experience in the pharmaceutical industry, Ricarda Leister is an accomplished leader in this field. As Head of Research & Development at MEGGLE Excipients, Ricarda manages a multidisciplinary team driving innovation in excipients and technology, as well as formulation support for pharmaceutical companies.</p> <p>Ricarda has held key leadership roles at STADA, Procter & Gamble, Merck, and Boehringer Ingelheim, where she gained extensive expertise in areas such as manufacturing science & technology, launch & transfers as well as quality management. She holds a degree in Pharmaceutical Engineering and an Executive MBA, supplemented by certifications such as SCRUM Master and Six Sigma Black Belt. Her core expertise lies in product and process technologies, including oral solid dosage forms, dry powder inhalation, spray-drying, and aseptic manufacturing. Ricarda is passionate about advancing science and technology, as well as digitalization. She is committed to fostering innovation and creating value for customers.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3210-dr-nathanael-page-uk"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Nathanael Page, UK</h2> <h3 class="detail__subtitle">Associate Scientific Director</h3> <div class="detail__perex"> <p><strong>Resolian</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2025/02/dr-nathanael-page-uk-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__content"> <p><span>Nathanael Page is an Associate Scientific Director at Resolian, specializing in chromatography and mass spectrometry for the quantitation and characterization of trace impurities in pharmaceuticals and medical devices. With an MSc in Analytical Chemistry from Loughborough University, Nathanael has provided technical guidance for the quantitation and characterization of nitrosamines and other impurities in numerous pharmaceuticals and medical devices. Nathanael's research interests revolve around enhancing the sustainability of impurity quantitation and characterization methods.</span></p> </div> </div> </div> <div class="detail detail--fancybox" id="all-speakers"> <div class="detail__container detail__container--cols"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Andrew Teasdale, UK </h2> <h3 class="detail__subtitle">Senior Principal Scientist / Head of Impurity Management & CMC Strategy</h3> <div class="detail__perex"> <h4><span>AstraZeneca</span></h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2022/03/dr-andrew-teasdale-uk-150x150px-300dpi-new.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Raphael Nudelman, IL </h2> <h3 class="detail__subtitle">Senior Director of Impurity Expert, R&D Operations</h3> <div class="detail__perex"> <h4><span>Teva Pharmaceutical Industries Ltd. </span></h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2020/02/5-dr-raphael-nudelman-il.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Lutz Mueller, CH</h2> <h3 class="detail__subtitle">Chair Translational Safety Committee Pharma Research and Early Development (pRED)</h3> <div class="detail__perex"> <h4>Hoffmann-La Roche</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/10/dr-lutz-mueller-ch-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Julien Patoor, CH</h2> <h3 class="detail__subtitle">Director Analytical Project Management | Technical R&D</h3> <div class="detail__perex"> <p><strong>Novartis Pharma AG</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/10/julien-patoor-ch-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Michelle Kenyon, US</h2> <h3 class="detail__subtitle">Research Fellow I Drug Safety Toxicology Impurity Risk Management</h3> <div class="detail__perex"> <p><strong>Pfizer</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/09/michelle-kenyon-us-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Mark Harrison, UK</h2> <h3 class="detail__subtitle">Associate Principal Scientist - Trace EWG</h3> <div class="detail__perex"> <p><strong>AstraZeneca</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/03/dr-mark-harrison-uk-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Mayur Mitra, US</h2> <h3 class="detail__subtitle">Distinguished Scientist and Director</h3> <div class="detail__perex"> <p><strong>Genentech</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/09/dr-mayur-mitra-us-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Rok Grahek, SL</h2> <h3 class="detail__subtitle">Department Head</h3> <div class="detail__perex"> <h4>SDC Slovenia, Lek d.d., Sandoz</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/11/dr-rok-grahek-sl-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Carla Landolfi, IT</h2> <h3 class="detail__subtitle">European Registered Toxicologist (ERT) CEO - Toxicology Risk Assessor</h3> <div class="detail__perex"> <h4>ToxHub</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2022/09/dr-carla-landolfi-it-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Paulo Eliandro da Silva Junior, BR </h2> <h3 class="detail__subtitle">Technical and Regulatory Director</h3> <div class="detail__perex"> <h4>INTEGRA CONSULTANCY</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2022/09/dr-paulo-eliandro-da-silva-junior-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Alexander Amberg, DE </h2> <h3 class="detail__subtitle">Head of In Silico Toxicology / R&D Preclinical Safety FF </h3> <div class="detail__perex"> <h4>Sanofi Aventis Deutschland GmbH</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/11/dr-alexander-amberg-de-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. George Johnson, UK</h2> <h3 class="detail__subtitle">Associate Professor</h3> <div class="detail__perex"> <h4><strong>Institute of Life Science at Swansea University</strong></h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2020/03/12-dr-george-johnson-uk-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Ricarda C. Leister, DE</h2> <h3 class="detail__subtitle">Head of Research & Development</h3> <div class="detail__perex"> <p><strong>MEGGLE Excipients</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2025/01/ricarda-c-leister-de-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Nathanael Page, UK</h2> <h3 class="detail__subtitle">Associate Scientific Director</h3> <div class="detail__perex"> <p><strong>Resolian</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2025/02/dr-nathanael-page-uk-150x150px-300dpi-_new.png)"></div> </div> </div> </div> <div class="ebook"> <div class="ebook__img" style="background-image: url(/files/2024/08/9th-genotoxic-banner-with-hashtag.jpg)"></div> <div class="ebook__content"> <h2>BROCHURE</h2> <p>Request the<strong> 9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit </strong>brochure and find out the latest topics and ideas that will be shared.</p> </div> <div class="ebook__link"> <a class="btn btn--fullw" href="#more2" data-fancybox id="more">GET IT NOW</a> </div> </div> <div class="detail detail--form detail--fancybox" id="more2"> <div class="detail__container"> <h2 class="detail__title">Request</h2> <div class="detail__perex"> <p>Please fill in your e-mail address below and we will process your request in a moment.</p> </div> <div class="detail__content"> <form class="form" id="ebook-request-form" action="/en/9th-impurities-genotoxic-nitrosamine-beyond-summit" method="post"> <input type="hidden" value="NUZQcHFvakZEeWlpWUpPNVN5d1RuamdTZkNyT245dW6QNd43_sGvh-8p69XESkWgWdNoYe0h-MR61lRFykAoPw==" name="YII_CSRF_TOKEN" /> <div class="anchor" id="form"></div> <div class="form__items"> <div class="form__item"> <label class="form__label required" for="EbookRequest_name">Name*</label> <input class="form__input" name="EbookRequest[name]" id="EbookRequest_name" type="text" maxlength="255" /> <div class="form__error" id="EbookRequest_name_em_" style="display:none"></div> </div> <div class="form__item"> <label class="form__label required" for="EbookRequest_email">E-mail*</label> <input class="form__input" name="EbookRequest[email]" id="EbookRequest_email" type="email" maxlength="255" /> <div class="form__error" id="EbookRequest_email_em_" style="display:none"></div> </div> </div> <div class="form__accept"> <input id="ytEbookRequest_tos" type="hidden" value="0" name="EbookRequest[tos]" /><input class="checkbox" name="EbookRequest[tos]" id="EbookRequest_tos" value="1" type="checkbox" /> <label for="EbookRequest_tos">I confirm that I have read and agreed to <a target="_blank" href="/en/terms-conditions">Terms & Conditions</a> and <a target="_blank" href="/en/privacy-policy">GDPR</a>.</label> <div class="form__error" id="EbookRequest_tos_em_" style="display:none"></div> </div> <input name="EbookRequest[www]" id="EbookRequest_www" type="hidden" /> <div class="form__error" id="EbookRequest_www_em_" style="display:none"></div> <div class="form__link"> <button class="btn btn--g btn--wtext btn--wide">Get it now</button> </div> </form> </div> </div> </div> <div class="micsec"> <div class="micsec__row"> <h2 class="micsec__title">Sponsors</h2> <div class="micsec__buttons"> <a class="btn btn--w" href="/en/9th-impurities-genotoxic-nitrosamine-beyond-summit/sponsorships">BECOME A SPONSOR</a> </div> </div> <div class="sponsors"> <a class="sponsors__item" href="http://www.resolian.com/" style="background-image: url(/files/2024/03/resolian_sponsor-for-web-300x300px.png)">Resolian</a> <a class="sponsors__item" href="https://www.qualimetrix.com/" style="background-image: url(/files/2025/02/qualimetrix-s-a-_sponsor-for-web-300x300px.png)">QualiMetrix S.A</a> <a class="sponsors__item" href="https://www.meggle-pharma.com/" style="background-image: url(/files/2025/02/meggle-excipients_sponsor-for-web-300x300px.png)">MEGGLE Excipients</a> </div> </div> </div> </div> </div> </div> <div class="say"> <div class="say__container"> <h2 class="say__whatsay">What our<br/>participants<br/> are saying</h2> <div class="say__slide slick" data-length="3"> <div class="say__item say__item--no-img"> <div class="say__bubble"> <div class="say__text"> <p>“Attending the <strong>#VLgenotoxic</strong> Summit was a game-changer for our team. The depth of knowledge shared on genotoxic impurities and nitrosamines was unparalleled. The expert presentations and interactive discussions provided us with actionable strategies that we immediately implemented in our processes. This summit is a must-attend for anyone serious about staying ahead in pharmaceutical safety and compliance."</p> </div> <div class="say__rating"> <div class="say__star say__star--active"> 1 </div> <div class="say__star say__star--active"> 2 </div> <div class="say__star say__star--active"> 3 </div> <div class="say__star say__star--active"> 4 </div> <div class="say__star say__star--active"> 5 </div> </div> </div> <div class="say__man"> <div class="say__r"> <h3 class="say__title">Emily</h3> <p class="say__subtext">Director of Quality Assurance</p> </div> </div> </div> <div class="say__item say__item--no-img"> <div class="say__bubble"> <div class="say__text"> <p>"The <strong>8th Impurities: Genotoxic, Nitrosamine, & Beyond Summit</strong> exceeded my expectations. The focus on the latest regulatory changes and practical approaches to impurity control was exactly what our organization needed. The networking opportunities were invaluable, allowing us to connect with industry leaders and forge partnerships that will drive our projects forward. I highly recommend this event to professionals across the pharmaceutical industry."</p> </div> <div class="say__rating"> <div class="say__star say__star--active"> 1 </div> <div class="say__star say__star--active"> 2 </div> <div class="say__star say__star--active"> 3 </div> <div class="say__star say__star--active"> 4 </div> <div class="say__star say__star--active"> 5 </div> </div> </div> <div class="say__man"> <div class="say__r"> <h3 class="say__title">John Mitchell</h3> <p class="say__subtext">Senior Regulatory Affairs Manager</p> </div> </div> </div> <div class="say__item say__item--no-img"> <div class="say__bubble"> <div class="say__text"> <p>"#VLgenotoxic was an incredible opportunity to dive deep into the complexities of impurity management. The case studies and technical sessions were insightful, providing real-world examples and innovative solutions. The discussions on nitrosamines and elemental impurities were particularly relevant to the challenges we face today. I walked away with a wealth of knowledge and new connections that will benefit our company for years to come."</p> </div> <div class="say__rating"> <div class="say__star say__star--active"> 1 </div> <div class="say__star say__star--active"> 2 </div> <div class="say__star say__star--active"> 3 </div> <div class="say__star say__star--active"> 4 </div> <div class="say__star say__star--active"> 5 </div> </div> </div> <div class="say__man"> <div class="say__r"> <h3 class="say__title">Sarah Lopez</h3> <p class="say__subtext">Head of Analytical Development</p> </div> </div> </div> </div> </div> </div> <div class="sector sector--sizeS"> <div class="sector__container"> <div class="micsec micsec--maxwidth"> <div class="micsec__row"> <h2 class="micsec__title">Gallery</h2> <div class="micsec__folders"> <ul class="folders"> <li class="folders__item active" data-tabs="gallery-v2" data-show="1"> <p class="folders__date">Mar 15, 2023</p> <p class="folders__name">7th Impurities: Genotoxic, Nitrosamine & Beyond Summit</p> </li> <li class="folders__item active" data-tabs="gallery-v2" data-show="2"> <p class="folders__date">Jun 13, 2019</p> <p class="folders__name">3rd Annual Impurities: Genotoxic and Beyond Summit </p> </li> </ul> </div> </div> <div class="egallery2 egallery2--withVideo active" data-tabs="gallery-v2" data-id="1"> <a class="egallery2__video" data-fancybox="gallery" href=""> <div class="egallery2__inner" style="background-image: url(/files/2023/05/th_309ac4095c2904c13c63a07f27f9b521.jpg"></div> </a> <div class="egallery2__images"> <a class="egallery2__img" data-fancybox="gallery" href="/files/2023/03/7th-impurities-genotoxic-nitrosamine-and-beyond-summit-by-vonlanthen11.jpg"> <div class="egallery2__inner" style="background-image: url(/files/2023/05/th_309ac4095c2904c13c63a07f27f9b521.jpg )"> </div> </a> <a class="egallery2__img" data-fancybox="gallery" href="/files/2023/03/7th-impurities-genotoxic-nitrosamine-and-beyond-summit-by-vonlanthen10.jpg"> <div 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