Sections Pharmaceutical Toxicology and Genetic Toxicology
INVITATION: Spring symposium - Wednesday afternoon April 24, 2024
Utrecht Science Park, Ruppertgebouw, zaal Rood
Address: Leuvenlaan 21, Utrecht
Genotoxic impurities in pharmaceutical products
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 “N-nitrosamine” impurities. For example, since 2018, numerous lots of valsartan were found to contain higher than acceptable levels of N‐nitrosodimethylamine (NDMA). N-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.
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.
| Program | |||
| 13.15 – 13.30
13:15 – 13.50 | Business meeting (Huishoudelijke vergadering), Section Pharmaceutical toxicology members only Registration, coffee and tea | ||
| 13.50 – 14.00 | Welcome & Instructions Day chair: Daan Touw, UMCG | ||
| 14:00 – 14.30 | Management of (geno)toxic impurities – a view from pharma industry Dr. Miranda Cornet, Director Non-Clinical Safety at UCB Biopharma | ||
| 14.30 – 15:00 | Ames Test assay parameters important for the detection of N-Nitrosamine mutagenicity Anthony Lynch, Head of Genetic Investigative Toxicology at GSK | ||
| 15:00 – 15:30 | Break | ||
| 15:30 – 16:00 | Regulatory experience with nitrosamine impurities in pharmaceuticals. Dr. Leon van Aerts, Senior non-clinical assessor at CBG | ||
| 16:00 – 16:30 | Nitrosamine: communication to patients and consumers. Feyzullah Mermi, pharmacist at KNMP | ||
| 16:30 – 16:50 16:50 – 17:30 | Discussion & wrap-up Social get together and drinks | ||
Registration:
- Deadline: 15th of April
- Email to: Wianda Goense (w.a.goense@umcg.nl), with subject “Registration NVT spring symposium – 24 April”
- Please indicate: Name and affiliation
There will be no charge for attending this symposium
A certificate of attendance will be sent within a few weeks after the symposium.