Menu
Date: 2nd-3rd of October 2025
Language: English
Key poins:
Welcome to the Global Impurity Control: Genotoxicity, Nitrosamines, and Beyond 2025 Conference
We are excited to invite you to join us at the “Global Impurity Control: Genotoxicity, Nitrosamines, and Beyond 2025 Conference”, where leading experts will explore the latest strategies, technologies, and regulatory frameworks to address the critical challenges posed by drug impurities. Over the course of this conference, we will delve into cutting-edge testing methods, risk management approaches, and the role of innovative solutions like AI in enhancing the safety and efficacy of pharmaceutical products. Together, we will share insights and collaborate on advancing the future of pharmaceutical safety and compliance.
The conference is designed for professionals working in the pharmaceutical, biotech, and medical device industries, including:
Whether you’re involved in the development, testing, or regulation of pharmaceutical products, this event provides a unique opportunity to stay ahead of evolving industry standards and regulatory requirements.
Access to Valuable Resources: Gain insights from research papers, case studies, and tools to enrich your projects.
Exposure to Cutting-Edge Ideas: Discover innovative approaches and fresh perspectives to refine your strategies.
Industry Insights and Expert Guidance: Learn directly from industry leaders, thought-provoking speakers, and experts.
Building Meaningful Connections: Form valuable relationships with peers, industry leaders, and potential mentors.
Hands-on Learning and Practical Applications: Participate in interactive sessions and workshops to apply new knowledge.
Enhanced Professional Visibility: Elevate your professional presence within your industry and field.
Cultural and Global Insights: Gain diverse perspectives and insights into global practices.
Enjoy a Memorable Experience: Participate in engaging sessions and activities that create lasting memories.
The “Global Impurity Control: Genotoxicity, Nitrosamines, and Beyond 2025 Conference” will bring together leading experts from the pharmaceutical, regulatory, and analytical communities to address the critical issues surrounding impurities in drug development. This two-day event will explore a wide array of topics, including risk assessment strategies, the latest advancements in analytical technologies, and regulatory approaches for controlling genotoxic impurities, such as nitrosamines. Key sessions will cover mass spectrometry, emerging contaminants, and the latest trends in in vitro and in vivo genotoxicity testing. The conference will also focus on specific challenges faced in biopharmaceuticals, APIs, drug-device combination products, and biologics, as well as the evolving regulatory landscape. Alongside expert presentations and interactive workshops, participants will have invaluable networking opportunities to connect with industry leaders, foster collaborations, and share insights with peers. The event promises to offer essential knowledge and actionable strategies to ensure safety and regulatory compliance in the pharmaceutical industry.
We are honored to host the ”Global Impurity Control: Nitrosamines, Genotoxicity, and Beyond 2025 Conference in the timeless city of Rome, a place celebrated for its rich cultural heritage and historical significance. Known for its prominence in education and innovation, Rome provides an unparalleled setting to bring together leaders from the pharmaceutical, biotechnology, and regulatory fields. With excellent international access, state-of-the-art venues, and a refined atmosphere, Rome ensures a seamless and enriching conference experience. Beyond the professional opportunities, the city’s vibrant cultural and historical offerings promise a truly unforgettable journey for all attendees.
© 2023-2024 VNA International
Global Impurity Control: Genotoxicity, Nitrosamines, and Beyond 2025 Conference
Rose-Marie Jenvert has over 20 years of experience within the medical device, pharma and biotechnology industry, and is currently working as Biocompatibility Specialist at Veranex, located in Lund Sweden. Rose-Marie is an experienced method developer of in vitro methods and holds a MSc in Molecular Biology and a PhD in Cell Biology. She has experience in performing biological evaluations of medical devices and has previously worked as study director for biocompatibility studies, setting up testing strategies and coordinating biological and chemical testing. She also has hands-on experience of testing different materials and medical devices.
Rose-Marie is actively working as an expert in ISO/TC194 WG8 with updating of the standards for skin sensitization and skin irritation (ISO 10993-10 and -23), and is also involved in the work of WG5, the standard for cytotoxicity.
Michael works as a Biocompatibility Specialist at Sonova AG, focusing on evaluating and implementing biocompatibility testing strategies for medical devices and materials. Furthermore, he has experience as a project manager in Product Stewardship, ensuring safety and regulatory compliance in the chemical sector. Since his Ph.D. in environmental toxicology, Michael consistently emphasized the development and application of innovative in vitro methods, such as the development of novel cell lines for toxicity screening. He will share practical insights and present case studies about his experience using in vitro sensitization methods for medical devices.
Jan Wirsching has many years of experience in the medical device industry working in the field of biocompatibility and material compliance, and is currently working at Maquet Cardiopulmonary GmbH, a Getinge Company. Jan holds degrees in Molecular Medicine and Toxicology. He has experience in performing biological evaluations, toxicological risk assessments and material compliance evaluations for a wide range of devices, including combination products. Jan Wirsching is actively working as an expert in the development of a guideline on characterizing and assessing nanomaterials in medical devices and in vitro diagnostics (VDI 5709).
Theme: Complexity of Combination Products: Drug Device Interactions
– What are drug device interactions and how to investigate them?
– How do drug device interactions influence the biological risk assessment?
– Case Study: Biological risk assessment of a Heparin/Albumin-coated combination product
Fabian Kriegel is currently Head of Material Development and Biocompatibility at Carl Zeiss Meditec AG, where he leads a dynamic team focused on the development of biocompatible materials, particularly for ophthalmic applications. Together with his dedicated team, Fabian ensures the seamless implementation of testing strategies in accordance with international standards for safety and efficacy. His expertise also extends to guiding projects through the complex processes of international regulatory approval, facilitating the acceptance of medical devices on a global scale.
Prior to his current role, Fabian held positions such as GLP Study Director and Genetic Toxicology Laboratory Manager in the pharmaceutical industry. Academically, Fabian has contributed to various research areas such as nanomaterial toxicity, analytical chemistry and computational biology. In addition, he is recognized as a European Registered Toxicologist and an active member of various toxicology societies.
