The webinar discussed the essential aspects of nitrosamines impurities, which can be carcinogenic and require manufacturers to evaluate their products.
This Tuesday 27th October Azierta organized a professional webinar on nitrosamines impurities with 231 attendees. Ana Maria Castro, Industrial Area Manager, and Javier Fernandez, Senior Toxicology Officer, presented the content in two different blocks with special attention to the control and surveillance strategy.
The purpose of this webinar, which was developed online, is to provide guidance on how Marketing Authorisation Holders (MAHs) should conduct a proper analysis of products at risk of containing nitrosamines impurities, which could lead manufacturers to change the manufacturing process. The FDA and the EMA are providing MAHs with guidance on how to comply with this measure after it has been demonstrated that nitrosamines impurities can be carcinogenic.
New deadlines have been agreed for mandatory risk assessment, 31 March 2021 for chemical medicines and 1 July 2021 for biological medicines.
Azierta has a professional and multidisciplinary team of experts with great experience in the implementation of ICH Q9 quality management regulations and in the evaluation and control of mutagenic impurities according to ICH M7. It also has a specialised toxicological support area accredited by AETOX, EUROTOX and ERT.
Azierta is a consultancy firm specialised in Science and Health that is committed to promoting the relationship between science and the business environment through the "Science to Business" concept.