Date: 2027
Language: English
Key poins:
We are thrilled to invite you to the 2nd Annual Global Impurity Control: Genotoxicity, Nitrosamines, and Beyond 2027 Conference, taking place in the beautiful and historic city of Prague.
This international gathering will bring together leading experts from across the pharmaceutical, biotechnology, and regulatory sectors to exchange knowledge and address the evolving challenges of impurity control, genotoxic impurities, nitrosamines, and emerging contaminants.
Over the course of two days, attendees will benefit from insightful keynote presentations, expert-led panel discussions, case studies, and valuable networking opportunities. The programme is designed to explore the latest scientific, analytical, toxicological, and regulatory developments, while fostering collaboration and innovation across the industry.
Whether your focus is on R&D, analytical sciences, toxicology, quality assurance, quality control, manufacturing, regulatory affairs, compliance, or data science, this event offers a unique platform to gain practical insights, share experiences, and connect with industry leaders.
Join us in Prague for an engaging and thought-provoking experience as we explore the future of impurity control and work together to advance patient safety, product quality, and regulatory excellence.
We look forward to welcoming you to Prague for an unforgettable conference experience.
The conference is designed for professionals working in the pharmaceutical, biotech, and medical device industries, including:
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.
Whether you are 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.
We are delighted to welcome you to Prague for the 2nd Annual Global Impurity Control: Nitrosamines, Genotoxicity, and Beyond 2027 Conference, set in one of Europe’s most captivating and historically rich capitals.
Renowned for its architectural beauty, scientific excellence, and long-standing tradition of intellectual exchange, Prague offers an inspiring backdrop for bringing together global leaders from the pharmaceutical, biotechnology, and regulatory communities.
With its central European location, excellent international connectivity, and modern conference facilities seamlessly integrated into a historic urban landscape, Prague provides an ideal environment for meaningful collaboration and productive dialogue.
Beyond the professional program, attendees will have the opportunity to experience the city’s iconic skyline, winding cobblestone streets, and vibrant cultural life, ensuring a truly memorable journey.
2nd Annual Global Impurity Control: Genotoxicity, Nitrosamines, and Beyond 2027 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.
