{"id":9907,"date":"2024-02-23T06:32:19","date_gmt":"2024-02-23T06:32:19","guid":{"rendered":"https:\/\/toxicologie.nl\/?p=9907"},"modified":"2024-03-15T07:57:10","modified_gmt":"2024-03-15T07:57:10","slug":"april-24th-2024-spring-symposium-sections-pharmaceutical-toxicology-and-genetic-toxicology","status":"publish","type":"post","link":"https:\/\/toxicologie.nl\/en\/april-24th-2024-spring-symposium-sections-pharmaceutical-toxicology-and-genetic-toxicology\/","title":{"rendered":"April 24th, 2024 Spring Symposium Sections Pharmaceutical Toxicology and Genetic Toxicology"},"content":{"rendered":"

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Sections\u00a0Pharmaceutical Toxicology and Genetic Toxicology<\/strong><\/p>\n

INVITATION: Spring symposium - Wednesday afternoon April 24, 2024<\/strong><\/p>\n

Utrecht Science Park, Ruppertgebouw, zaal Rood<\/p>\n

Address: Leuvenlaan 21, Utrecht<\/p>\n

Genotoxic impurities in pharmaceutical products<\/strong><\/p>\n

The manufacturing process of pharmaceuticals is often based on a number of chemical reactions. During this process, byproducts called impurities may be formed that might still be present at low levels in the end-product. Strict ICH guidelines are in place to control these levels at acceptable amounts. The lowest acceptable levels are applied to potential genotoxic impurities. An example of such impurities that have had a lot of attention the last few years are the \u201cN<\/em>-nitrosamine\u201d impurities. For example, since 2018, numerous lots of valsartan were found to contain higher than acceptable levels of\u00a0N<\/em>\u2010nitrosodimethylamine (NDMA). N<\/em>-nitrosamines are often genotoxic and potent human mutagens. In this spring symposium, the invited speakers will give an overview of the challenges related to genotoxic impurities in pharmaceutical products, from a regulatory, academic, industry and patient communication point of view.<\/p>\n

During the symposium there will be sufficient time to discuss and ask questions to the speakers and other attendees. We hope it will be an inspiring, thought-provoking, and informative meeting.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
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Program <\/strong><\/td>\n

<\/td>\n<\/td>\n<\/tr>\n
13.15 \u2013 13.30<\/p>\n

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13:15 \u2013 13.50<\/td>\n

Business meeting (Huishoudelijke vergadering), Section Pharmaceutical toxicology members only<\/p>\n

Registration, coffee and tea<\/td>\n<\/tr>\n

13.50 \u2013 14.00<\/td>\nWelcome & Instructions<\/p>\n

Day chair: Daan Touw, UMCG<\/em><\/td>\n<\/tr>\n

14:00 \u2013 14.30<\/td>\nManagement of (geno)toxic impurities \u2013 a view from pharma industry<\/p>\n

Dr. Miranda Cornet, Director Non-Clinical Safety at UCB Biopharma \u00a0<\/em><\/td>\n<\/tr>\n

14.30 \u2013 15:00<\/td>\nAmes Test assay parameters important for the detection of N<\/em>-Nitrosamine mutagenicity<\/p>\n

Anthony Lynch, Head of Genetic Investigative Toxicology at <\/em>GSK<\/em><\/td>\n<\/tr>\n

15:00 \u2013 15:30<\/td>\nBreak<\/td>\n<\/tr>\n
15:30 \u2013 16:00<\/td>\nRegulatory experience with nitrosamine impurities in pharmaceuticals.<\/p>\n

Dr. Leon van Aerts, Senior non-clinical assessor at CBG<\/em><\/td>\n<\/tr>\n

16:00 \u2013 16:30<\/td>\nNitrosamine: communication to patients and consumers.<\/p>\n

Feyzullah Mermi, pharmacist at KNMP<\/em><\/td>\n<\/tr>\n

16:30 \u2013 16:50<\/p>\n

16:50 \u2013 17:30<\/td>\n

Discussion & wrap-up<\/p>\n

Social get together and drinks<\/td>\n<\/tr>\n

<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Registration<\/strong>:<\/p>\n