8th Impurities: Genotoxic, Nitrosamine, & Beyond Summit

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Online</small> </li> <li class="info__address"> NH Danube City <small>Wagramer Strasse 21, 1220</small> </li> </ul> <div class="info__links"> <a class="btn btn--w btn--paddingS" target="_blank" href="https://maps.app.goo.gl/tNCqifmD5ziFk84y7">VENUE ADDRESS</a> <a class="btn btn--w btn--mmt" href="https://www.nh-hotels.com/en/hotel/nh-danube-city?utm_campaign=local-gmb&utm_medium=organic_search&utm_source=google_gmb">VENUE WEBSITE</a> </div> </div> <div class="edetail__perex"> <p style="text-align: justify;">Join us at the #VLgenotoxic 2024 event for enlightening keynote presentations, insightful case studies, engaging panel discussions, interactive Q&A sessions, and a chance to explore exhibitions. This conference will also provide ample opportunities to foster partnerships while gaining valuable insights into advanced strategies and perspectives within the realm of impurities and extractables and leachables (E&L). Save the date for the 8th Impurities: Genotoxic, Nitrosamine, & Beyond conference, taking place on April 10-11, 2024.</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 style="text-align: justify;">About the 8th Impurities: Genotoxic, Nitrosamine, & Beyond Summit (#VLgenotoxic)</h2> <p style="text-align: justify;">The Valsartan recall, attributed to the presence of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) impurities in widely prescribed pharmaceuticals, has initiated dynamic developments in the pharmaceutical landscape, yielding several key insights:</p> <ul style="text-align: justify;"> <li>The imperative need for investigating potential N-nitrosamine contamination and its mutagenic and carcinogenic risks to patients.</li> <li>Withdrawals, recalls, and clinical trial delays involving drugs such as ranitidine, nizatidine, metformin, rifampin/rifapentine, varenicline, and others.</li> <li>The critical importance of formulating a rational risk-assessment strategy to avoid both overestimation and underestimation of nitrosamine-related risks in pharmaceutical products.</li> </ul> <p style="text-align: justify;">Critical issues and lessons gleaned from the Valsartan incident encompass:</p> <ul style="text-align: justify;"> <li>Identification of potential gaps in current pharmaceutical practices that may divert attention from FDA and drug manufacturers concerning NMDA and NDEA impurities.</li> <li>Recent strategies and acceptable intake (AI) thresholds for nitrosamine impurities.</li> <li>Application of nitrosamine formation in risk assessment during pharmaceutical processes, encompassing drug substance (DS), drug product (DP), and drug product packaging (DPP).</li> <li>The need for pharmaceutical experts, in collaboration with researchers, academia, and toxicologists, to generate knowledge and methodologies shaping future regulations for controlling N-nitrosamines as mutagenic impurities in pharmaceuticals.</li> <li>The establishment of control strategies to minimise nitrosamine impurity presence, optimise manufacturing processes, and mitigate the carcinogenic risk to patients.</li> <li>The collaborative involvement of various stakeholders, including active pharmaceutical ingredient (API) manufacturers, excipient providers, primary packaging suppliers, and drug product manufacturers, due to the complexity of risk analysis.</li> </ul> <p style="text-align: justify;">At the #VLgenotoxic 2024 event, our focus will extend beyond N-nitrosamines, covering the following key areas:</p> <ul style="text-align: justify;"> <li>Illuminating crucial aspects of detecting and reporting genotoxic impurities in the pharmaceutical industry.</li> <li>Exploring ongoing investigations and addressing regulatory, toxicological, analytical, and pharmaceutical considerations related to genotoxic impurities (GTIs).</li> <li>Assessing the impact of implementing ICH M7 guidelines, offering guidance on the hazard identification and risk assessment process for genotoxic impurities in pharmaceuticals.</li> <li>Discussing relevant guidelines to prevent N-nitrosamine contamination in human medicines and alternative strategies for initial risk evaluation and confirmatory testing of drug products and APIs susceptible to N-nitrosamine formation.</li> <li>Continuing to explore recent advancements, further developments, and future considerations concerning various types of impurities found in drugs, including genotoxic impurities, nitrosamines, elemental impurities, extractables, leachables, and others.</li> </ul> <p style="text-align: justify;">The forward-looking 8th Impurities: Genotoxic, Nitrosamine, & Beyond Summit, scheduled for April 10-11, 2024, will be hosted by leading experts in the genotoxic and elemental impurities field.</p> <p style="text-align: justify;">Join us for keynote presentations, insightful case studies, interactive panel discussions, and Q&A sessions. Explore exhibitions and seize partnership opportunities while gaining valuable insights into advanced strategies and perspectives in the realm of impurities and extractables and leachables (E&L).</p> <p style="text-align: justify;">Engage in comprehensive presentations, technical training, and workshops, delving into recent advancements and challenges related to:</p> <ul style="text-align: justify;"> <li>Practical regulatory and toxicological considerations for efficient identification, monitoring, and control of mutagenic impurities (ICH M7).</li> <li>Critical issues and lessons learned concerning the quality, safety, and efficacy of drug products.</li> <li>Addressing uncertainties and misalignments in nitrosamine safety assessments.</li> <li>Regulatory requirements and perspectives on nitrosamines.</li> <li>Recent experiences with E&L and elemental impurities (ICH Q3D).</li> </ul> <p style="text-align: justify;">A digital certificate of attendance will be provided to #VLgenotoxic participants.</p> <h2 style="text-align: justify;">Who Should Attend:</h2> <p style="text-align: justify;">Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:</p> <ul> <li style="text-align: justify;">Analytical Science</li> <li style="text-align: justify;">API Development</li> <li style="text-align: justify;">Assay Development</li> <li style="text-align: justify;">Biotherapeutics</li> <li style="text-align: justify;">Carcinogenic Impurities</li> <li style="text-align: justify;">Carcinogenicity</li> <li style="text-align: justify;">Carcinogens</li> <li style="text-align: justify;">Chemistry (Analytical, Organic, Medicinal, Protein)</li> <li style="text-align: justify;">Chromatography</li> <li style="text-align: justify;">Degradation Products</li> <li style="text-align: justify;">DNA Reactive Impurities</li> <li style="text-align: justify;">DNA Reactivity</li> <li style="text-align: justify;">Drug Design</li> <li style="text-align: justify;">Drug Development</li> <li style="text-align: justify;">Drug Discovery</li> <li style="text-align: justify;">Drug Safety</li> <li style="text-align: justify;">Drug Substance</li> <li style="text-align: justify;">Elemental Impurities</li> <li style="text-align: justify;">Extractables & Leachables</li> <li style="text-align: justify;">Formulation</li> <li style="text-align: justify;">Genetic Toxicology</li> <li style="text-align: justify;">Genotoxic Impurities (GTI)</li> <li style="text-align: justify;">Genotoxicity</li> <li style="text-align: justify;">Genotoxin</li> <li style="text-align: justify;">GMP</li> <li style="text-align: justify;">Good Laboratory Practice</li> <li style="text-align: justify;">GRAs</li> <li style="text-align: justify;">GTIs</li> <li style="text-align: justify;">Impurities</li> <li style="text-align: justify;">In Silico</li> <li style="text-align: justify;">Large Molecule</li> <li style="text-align: justify;">LC-MS</li> <li style="text-align: justify;">Mass Spectrometry</li> <li style="text-align: justify;">Microscopy</li> <li style="text-align: justify;">Mutagenic Impurities</li> <li style="text-align: justify;">Mutagenicity</li> <li style="text-align: justify;">Nanomaterials</li> <li style="text-align: justify;">Nanoparticles</li> <li style="text-align: justify;">New Modality</li> <li style="text-align: justify;">Oligonucleotide</li> <li style="text-align: justify;">Organic Synthesis</li> <li style="text-align: justify;">Particles</li> <li style="text-align: justify;">Peptide</li> <li style="text-align: justify;">Potential Genotoxic Impurities (PGTIs)</li> <li style="text-align: justify;">Preclinical Drug Safety</li> <li style="text-align: justify;">Process Chemistry</li> <li style="text-align: justify;">Process-Related Impurities</li> <li style="text-align: justify;">Product-Related Impurities</li> <li style="text-align: justify;">Protein</li> <li style="text-align: justify;">Purification</li> <li style="text-align: justify;">Purge Factors</li> <li style="text-align: justify;">Quality Assurance (QA)</li> <li style="text-align: justify;">Quality By Design (QbD)</li> <li style="text-align: justify;">Quality Control (QC)</li> <li style="text-align: justify;">Regulatory</li> <li style="text-align: justify;">R&D</li> <li style="text-align: justify;">Safety Assessment</li> <li style="text-align: justify;">Small Molecule</li> <li style="text-align: justify;">Spectroscopy</li> <li style="text-align: justify;">Total Daily Intake (TDI)</li> <li style="text-align: justify;">Technology Transfer</li> <li style="text-align: justify;">Threshold of Toxicological Concern (TTC)</li> <li style="text-align: justify;">Toxicology</li> <li style="text-align: justify;">Validation</li> </ul> </div> </div> </div> <div class="edetail__links"> <a class="btn btn--w btn--paddingS" href="/en/8th-impurities-genotoxic-nitrosamine-beyond-summit/packages">REGISTER NOW</a> </div> <div class="edetail__topic"> <h2>Key Practical Learning Points</h2> <div class="elist elist--has-more"> <ul> <li>Critical factors for maintaining compliance when implementing ICH M7 and Q3D guidelines</li> <li>Effective control of DNA-reactive N-nitrosamine impurities to mitigate potential carcinogenic risks</li> <li>Navigating uncertainties, resolving misalignments, and benefiting from insights related to nitrosamines</li> <li>Exploring cutting-edge techniques, technologies for the identification, monitoring, and control of GI</li> <li>Advancing risk assessment and exploring guidance on the safe qualification of impurities</li> <li>Addressing potential gaps that impact the identification and control of mutagenic impurities</li> <li>Navigating genotoxic impurities CMC regulations, potential pitfalls, and industry expectations</li> <li>Assessment, testing, and control of impurities in pharm products, drug substances/APIs, and excipients</li> <li>Thorough evaluation of E&L to assess genotoxicity risks and guarantee comprehensive safety assessments</li> <li>Updates, future prospects, and insights on analytical techniques, regulatory, and toxicology science</li> </ul> <button class="elist__more"></button> </div> </div> </div> <div class="edetail__col"> <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="#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="#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="#1257-dr-susanne-glowienke-ch" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2020/05/th_f2234e15faac74fea2d463ab586965d7.png)"></div> <h3 class="speakers__name">Dr. Susanne Glowienke, CH</h3> <h2 class="speakers__subtitle">Director, Preclinical Safety</h2> </div> <div class="speakers__text"><h4>Novartis Pharma AG</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="#3115-dr-kausik-k-nanda-us" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2023/11/th_1af354c92d52dd77439b115600407cc7.png)"></div> <h3 class="speakers__name">Dr. Kausik K Nanda, US</h3> <h2 class="speakers__subtitle">Principal Scientist</h2> </div> <div class="speakers__text"><h4>MSD (Merck Sharp & Dohme Corp.)</h4></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 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class="speakers__text"><h4>MoonWave Consulting</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="#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="#2910-dr-markus-obkircher-de" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2023/01/th_5e71a1af5a84a39c4c5e78b5331842b4.png)"></div> <h3 class="speakers__name">Dr. Markus Obkircher, DE</h3> <h2 class="speakers__subtitle">Director, Research & Development</h2> </div> <div class="speakers__text"><h4>Merck Life Science</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="#3117-dr-marko-trampuz-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_e66d448b3e555db64641b0da26ba7f98.png)"></div> <h3 class="speakers__name">Dr. Marko Trampuž, SL</h3> <h2 class="speakers__subtitle">Scientist, Early Development</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="#1661-dr-roustem-saiakhov-us" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2024/02/th_b36fd5d738c5e928a2a6a47051876b04.png)"></div> <h3 class="speakers__name">Dr. Roustem Saiakhov, US </h3> <h2 class="speakers__subtitle">President</h2> </div> <div class="speakers__text"><p><strong>MultiCASE, Inc.</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#2655-dr-aloka-srinivasan-us" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2022/03/th_80c0747ed05c3bbf4f24e2d0ab502f6e.png)"></div> <h3 class="speakers__name">Dr. Aloka Srinivasan, US</h3> <h2 class="speakers__subtitle">Principal and Managing Partner</h2> </div> <div class="speakers__text"><h4>RAAHA LLC</h4></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3181-dr-gabriela-silveira-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_880197fbc99fde73f79e103435157014.png)"></div> <h3 class="speakers__name">Dr. Gabriela Silveira, UK</h3> <h2 class="speakers__subtitle">Senior Application Scientist</h2> </div> <div class="speakers__text"><p><strong>Lhasa Limited</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3210-nathanael-page-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_d7e586fdba90e2ba9de5dabecf7437fe.png)"></div> <h3 class="speakers__name">Nathanael Page, UK</h3> <h2 class="speakers__subtitle">Principal Scientist </h2> </div> <div class="speakers__text"><p><strong>Resolian</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> <a class="speakers__item speakers__item--has-text" href="#3213-dr-yuriy-svartsov-ch" data-fancybox id="more"> <div class="speakers__inner"> <div class="speakers__main"> <div class="speakers__img" style="background-image: url(/files/2024/04/th_ded4b8bb4e9422b36dcadae396c555d7.png)"></div> <h3 class="speakers__name">Dr. Yuriy Svartsov, CH</h3> <h2 class="speakers__subtitle">Manager Global Business Development Chemicals & Pharma</h2> </div> <div class="speakers__text"><p><strong>Intertek (Schweiz) AG</strong></p></div> </div> <p class="speakers__about">About Speaker</p> </a> </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="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="1257-dr-susanne-glowienke-ch"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Susanne Glowienke, CH</h2> <h3 class="detail__subtitle">Director, Preclinical Safety</h3> <div class="detail__perex"> <h4>Novartis Pharma AG</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2020/03/1-dr-susanne-glowienke-ch-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Dr. Susanne Glowienke graduated from the University of Stuttgart-Hohenheim, Germany, in food chemistry/technology. She then undertook research in the area of analytical chemistry and obtained her PhD degree from the faculty of food technology (cereal chemistry) in 1997 at the same university. In 2000, she joined Novartis in Basel, Switzerland, as a postdoc in the area of Q(SAR) for toxicological endpoints. Susanne was working as a lab head for bacterial mutagenesis in genetic toxicology, preclinical safety and is responsible for the QSAR predictions and impurity/excipient assessments at Novartis. </p> <p style="text-align: justify;">Currently, Susanne is a director in preclinical safety at Novartis, Basel, Switzerland. She held several positions at Novartis, including positions in genetic toxicology and QSAR modelling. She is currently head of the impurity safety group and as such responsible for contaminant issues including nitrosamines. Susanne is part of and has led a number of industry expert groups within DruSafe IQ (US), European Federation of Pharmaceutical Industries and Associations (EFPIA), the Extractables and Leachables Safety Information Exchange (ELSIE), and several data sharing initiatives.</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="3115-dr-kausik-k-nanda-us"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Kausik K Nanda, US</h2> <h3 class="detail__subtitle">Principal Scientist</h3> <div class="detail__perex"> <h4>MSD (Merck Sharp & Dohme Corp.)</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/11/dr-kausik-k-nanda-us-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Kausik Nanda has more than 23 years of experience in the pharmaceutical industry. In his early career as a medicinal chemist, Kausik worked on discovery programs in the neuroscience, cardiovascular, and infectious disease areas, where his team successfully developed lead identification, lead optimisation, and pre-clinical candidates. In his later career, Kausik’s work focussed on solving a multitude of problems in the development area, arising from chemical interaction in the drug product. Primarily, Kausik’s work focusses on drug degradation, mutagenic impurities, nitrosamine risk assessment and novel formulations inhibiting nitrosamine formation. The range of activities encompasses early development through commercial launch.</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="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="3108-dr-jacky-van-gompel-be"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Jacky Van Gompel, BE</h2> <h3 class="detail__subtitle">Business Owner</h3> <div class="detail__perex"> <h4>MoonWave Consulting</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2020/03/5-dr-jacques-van-gompel-be-150x150px-300dpi.png)"></div> </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="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="2910-dr-markus-obkircher-de"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Markus Obkircher, DE</h2> <h3 class="detail__subtitle">Director, Research & Development</h3> <div class="detail__perex"> <h4>Merck Life Science</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/01/markus-obkircher-de-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Markus Obkircher is director of R&D, heading Merck’s reference materials and proficiency testing division with teams in the US and Switzerland. He is responsible for the in-house development of new analytical standards and certified reference materials under ISO/IEC 17025 and ISO 17034 double accreditation. Prior to this position he was R&D manager in Buchs, Switzerland, with a strong focus on synthesis, characterisation, and certification of reference materials. He joined Merck/Sigma-Aldrich eight years ago after heading the development unit for a custom API manufacturer. He completed his post-doctoral studies at Harvard in Boston and his PhD thesis in Basel, and further holds an executive MBA degree from the University of Zurich.</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="3117-dr-marko-trampuz-sl"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Marko Trampuž, SL</h2> <h3 class="detail__subtitle">Scientist, Early Development</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-marko-trampuz-sl-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p style="text-align: justify;">Dr. Marko Trampuž works as a scientist in the early development department in Sandoz Development Centre Slovenia, Lek Pharmaceuticals d.d. He obtained his MPharm degree in 2015 and PhD in chemical sciences in 2019 at the University of Ljubljana in Slovenia. His PhD research work focussed on particle engineering, polymorphism, and mathematical modelling of chemical processes, particularly crystallisation. After completing his PhD, he worked as a medicinal chemist at drug discovery and development platform in SciLifeLab in Stockholm, Sweden, specialising in drug discovery of novel drugs for psychiatric, autoimmune, and oncological disorders. Since joining Lek Pharmaceuticals d.d. in 2021, his main responsibilities have been the development of novel analytical approaches for N-nitrosamine impurities and complex APIs, utilising his skills in synthetic organic chemistry and various spectroscopic methods.</p> </div> </div> </div> <div class="detail detail--fancybox" id="1661-dr-roustem-saiakhov-us"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Roustem Saiakhov, US </h2> <h3 class="detail__subtitle">President</h3> <div class="detail__perex"> <p><strong>MultiCASE, Inc.</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/02/dr-roustem-saiakhov-us-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__content"> <p>Dr. Roustem Saiakhov first joined MultiCASE in 2000 as a computational scientist. He was quickly promoted to the positions of Vice President of Research and Development, Chief Operating Officer, and has served as the company’s President since 2012. Dr. Saiakhov is a Native of Russia. In 1991, he was awarded a Ph.D. through the Kazan State University, the third oldest university of the Russian Federation. There, he studied the quantitative structure-activity relationship of complex element organic compounds with advisors Professor Vladimir Galkin and Professor Rafael Cherkasov. In 1995, Dr. Saiakhov joined Professor Michalski’s group at the Polish Academy of Science as a postdoctoral chemist. He relocated to the United States in 1997, joining Dr. Gilles Klopman’s group at Case Western Reserve University as a postdoctoral scientist. With over 25 years of experience in teaching and research, his expertise includes cheminformatics, molecular modeling, QSAR, organic and computational chemistry, and computational toxicology. Dr. Saiakhov also performs expert review on behalf of MultiCASE through its risk assessment and safety consulting services. He has been the principal investigator on numerous grant projects and has over 120 scientific publications and presentations.</p> </div> </div> </div> <div class="detail detail--fancybox" id="2655-dr-aloka-srinivasan-us"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Aloka Srinivasan, US</h2> <h3 class="detail__subtitle">Principal and Managing Partner</h3> <div class="detail__perex"> <h4>RAAHA LLC</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2022/03/dr-aloka-srinivasan-us-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p>Aloka Srinivasan, PhD, the principal and managing partner of RAAHA LLC (www.raahallc.com) has more than two decades of experience in the pharmaceutical industry, including nine years of progressive experience with the US FDA in the office of generic drugs, Lupin Pharmaceuticals, Lachman Consultants, and Parexel International.</p> <p>Prior to starting her own consulting, Aloka was the VP and head of regulatory at Lachman, VP of regulatory at Lupin, and principal at Parexel. Aloka spent more than nine years in the FDA’s office of generic drugs as a reviewer and team leader and spearheaded the establishment of a division for review of APIs in Type II DMFs. Aloka was also part of the team that initiated the question-based review (QbR– QOS) for generic drugs in CDER.</p> <p>Aloka is one of the world-class experts on nitrosamine based on her research background and has been supporting the industry in addressing these carcinogenic impurities in the drugs.</p> <p>She received her PhD from the University of Missouri, Columbia, under Dr. Richard N. Loeppky of nitrosamine fame. Her thesis was titled, “Putative Intermediates in Activation of Beta Hydroxy Nitrosamines”. Aloka also spent seven years as a scientist at National Cancer Institute, working for Dr. Larry K. Keefer, researching on nitrosamines in potential nitric oxide donor drugs.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3181-dr-gabriela-silveira-uk"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Gabriela Silveira, UK</h2> <h3 class="detail__subtitle">Senior Application Scientist</h3> <div class="detail__perex"> <p><strong>Lhasa Limited</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/03/dr-gabriela-silveira-uk-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p>Gabriela Silveira has strong academic and professional background in toxicological sciences, holding both master’s and PhD degrees in that same area. Relying on that background, Gabriela pursued a productive career as an independent consultant and as a toxicologist in the pharmaceutical industry in Brazil. Since then, Gabriela has become thoroughly familiar with regulatory guidelines, and to the evaluation of multiple toxicity endpoints in the context of toxicological risk assessments. Gabriela leads the complex nitrosamines data sharing initiative at Lhasa Limited and integrates the Kaptis for carcinogenicity and read-across teams at Lhasa.</p> </div> </div> </div> <div class="detail detail--fancybox" id="3210-nathanael-page-uk"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Nathanael Page, UK</h2> <h3 class="detail__subtitle">Principal Scientist </h3> <div class="detail__perex"> <p><strong>Resolian</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/03/nathanael-page-uk-150x150px-300dpi.png)"></div> </div> </div> </div> <div class="detail detail--fancybox" id="3213-dr-yuriy-svartsov-ch"> <div class="detail__container"> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Yuriy Svartsov, CH</h2> <h3 class="detail__subtitle">Manager Global Business Development Chemicals & Pharma</h3> <div class="detail__perex"> <p><strong>Intertek (Schweiz) AG</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/04/dr-yuriy-svartsov-ch-150x150px-300dpi.png)"></div> </div> <div class="detail__content"> <p>Dr. Yuriy Svartsov, originally from Ukraine, holds a PhD in Physical Chemistry from the Institute of Physical Chemistry and Spectroscopy of the Polish Academy of Sciences in Warsaw, Poland. After holding two academic post-doc positions in Germany (at Heinrich-Heine-Universität Düsseldorf) and Austria (at Johannes Kepler Universität Linz), he transitioned to the pharmaceutical industry, focusing on quality control of solid drug forms, and later, sales of products and services for the pharmaceutical sector. In 2023, he joined Intertek as a Global Business Development Manager.</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. 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. 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. Susanne Glowienke, CH</h2> <h3 class="detail__subtitle">Director, Preclinical Safety</h3> <div class="detail__perex"> <h4>Novartis Pharma AG</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2020/03/1-dr-susanne-glowienke-ch-150x150px-300dpi.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. Kausik K Nanda, US</h2> <h3 class="detail__subtitle">Principal Scientist</h3> <div class="detail__perex"> <h4>MSD (Merck Sharp & Dohme Corp.)</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/11/dr-kausik-k-nanda-us-150x150px-300dpi-_new.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. 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">Dr. Jacky Van Gompel, BE</h2> <h3 class="detail__subtitle">Business Owner</h3> <div class="detail__perex"> <h4>MoonWave Consulting</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2020/03/5-dr-jacques-van-gompel-be-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. 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">Dr. Markus Obkircher, DE</h2> <h3 class="detail__subtitle">Director, Research & Development</h3> <div class="detail__perex"> <h4>Merck Life Science</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2023/01/markus-obkircher-de-150x150px-300dpi.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. Marko Trampuž, SL</h2> <h3 class="detail__subtitle">Scientist, Early Development</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-marko-trampuz-sl-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Roustem Saiakhov, US </h2> <h3 class="detail__subtitle">President</h3> <div class="detail__perex"> <p><strong>MultiCASE, Inc.</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/02/dr-roustem-saiakhov-us-150x150px-300dpi-_new.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Aloka Srinivasan, US</h2> <h3 class="detail__subtitle">Principal and Managing Partner</h3> <div class="detail__perex"> <h4>RAAHA LLC</h4> </div> </div> <div class="detail__img" style="background-image: url(/files/2022/03/dr-aloka-srinivasan-us-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Gabriela Silveira, UK</h2> <h3 class="detail__subtitle">Senior Application Scientist</h3> <div class="detail__perex"> <p><strong>Lhasa Limited</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/03/dr-gabriela-silveira-uk-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Nathanael Page, UK</h2> <h3 class="detail__subtitle">Principal Scientist </h3> <div class="detail__perex"> <p><strong>Resolian</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/03/nathanael-page-uk-150x150px-300dpi.png)"></div> </div> <div class="detail__speakers"> <div class="detail__about"> <h2 class="detail__title">Dr. Yuriy Svartsov, CH</h2> <h3 class="detail__subtitle">Manager Global Business Development Chemicals & Pharma</h3> <div class="detail__perex"> <p><strong>Intertek (Schweiz) AG</strong></p> </div> </div> <div class="detail__img" style="background-image: url(/files/2024/04/dr-yuriy-svartsov-ch-150x150px-300dpi.png)"></div> </div> </div> </div> <div class="ebook"> <div class="ebook__img" style="background-image: url(/en/file/33287)"></div> <div class="ebook__content"> <h2><strong>RECORDING and PRESENTATION MATERIALS</strong></h2> <p><span>Request <strong>8th Impurities: Genotoxic, Nitrosamine, & Beyond Summit</strong> recording, brochure, and authorised presentation materials, and find out the latest topics and ideas that were shared during the event.</span><span> </span></p> </div> <div class="ebook__link"> <a class="btn btn--fullw" href="#more2" data-fancybox id="more">GET IT NOW</a> </div> 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</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/8th-impurities-genotoxic-nitrosamine-beyond-summit/sponsorships">BECOME A SPONSOR</a> </div> </div> <div class="sponsors"> <a class="sponsors__item" href="http://multicase.com" style="background-image: url(/files/2024/02/multicase-logo_sponsor-for-web-300x300px-new-20-02-2024.png)">Multi case</a> <a class="sponsors__item" href="https://www.lhasalimited.org/" style="background-image: url(/files/2023/02/lhasa-limited_sponsor-for-web-300x300px.png)">Lhasa Limited</a> <a class="sponsors__item" href="https://www.intertek.com/analytical-laboratories/switzerland/" style="background-image: url(/files/2020/09/intertek-2018-_sponsor-for-web-300x300px-2.png)">Intertek 2024</a> <a class="sponsors__item" href="https://brightlabs.nl/en/pharma-en/" style="background-image: 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The depth of knowledge and expertise shared by the speakers and panellists was unparalleled. I left with a clearer understanding of the earliest practices related to genotoxic impurities and their impact on pharmaceuticals. This event is a must for anyone in the industry who wants to stay ahead of the curve.</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">PREVIOUS</h3> <p class="say__subtext">Attendee</p> </div> </div> </div> <div class="say__item say__item--no-img"> <div class="say__bubble"> <div class="say__text"> <p style="text-align: justify;">The #VLgenotoxic exceeded all my expectations. The sessions were not only informative but also highly engaging. The discussions on nitrosamine contamination and its regulatory implications were particularly insightful. I left the summit with valuable insights and practical strategies that I could immediately apply to my work.</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">PREVIOUS</h3> <p class="say__subtext">Attendee</p> </div> </div> </div> <div class="say__item say__item--no-img"> <div class="say__bubble"> <div class="say__text"> <p style="text-align: justify;">I had the privilege of attending the #VLgenotoxic Summit, and it was truly enlightening. The diverse range of topics covered, from genotoxic impurities to E&L considerations, provided a comprehensive overview of the challenges faced by the pharmaceutical industry. The networking opportunities were also fantastic, allowing me to connect with experts in the field. I can't wait for the next summit!</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">PREVIOUS</h3> <p class="say__subtext">Attendee</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> </ul> </div> </div> <div class="egallery2 egallery2--withVideo active" 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