21 January 2020
2020 Webinar - Risk Assessment and Regulatory Decision Making for Alkyl Nitrosamines
Join guest speakers, Senior Principal Scientist, Andrew Teasdale from AstraZeneca, and Associate Professor of Biomedical Sciences, George Johnson, from Swansea University, as they present on Risk Assessment and Regulatory Decision Making for Alkyl Nitrosamines, in this free to attend webinar. Lhasa Limited Senior Scientist, Mike Burns, will also be on hand to answer questions at the end of the webinar.
In July 2018 the EMA announced the recall of Valsartan due to contamination with an N-Nitrosamine, specifically Nitrosodimethylamine (NDMA). N-Nitrosamines are potent animal carcinogens and belong to a special class defined as the Cohort of Concern. Further investigation implicated other suppliers as well as other drugs in the same class. These investigations also identified other N-Nitrosamines, some of which could not have occurred as a result of the process, highlighting potential cross contamination e.g. NDMA was even found in a non-sartan, pioglitazone. More recently Ranitidine was reported to also be contaminated with NDMA prompting its widespread withdrawal. In response to these issues and widespread concern, EMA recently published a request to evaluate the risk of the presence on nitrosamine impurities in ALL human medicinal products containing chemically synthesised active pharmaceutical ingredients. In this webinar, Andrew Teasdale and George Johnson will discuss the implications of these developments to the pharmaceutical industry and examine the types of data that can be used when determining safety limits.
This virtual event will begin at 14.30 (UK time).
Delegates require an internet connection and either a telephone or speakers (it is not essential to have access to a microphone).
This event will last approximately 90 to 120 minutes and will feature presentations followed by a Q&A session.
Headline Event (shown first above featured)
- Management of N-Nitrosamines - Use of Mirabilis based purge calculations to understand MI related risk and control strategy options
- Quantitative Analysis of In Vivo Dose-Response Data for Risk Assessment and Regulatory Decision Making - A Case Study of Alkylnitrosamines
- Quantitative Analysis of In Vivo Dose-Response Data for Risk Assessment and Regulatory Decision Making - Recording
- Management of N-Nitrosamines - Use of Mirabilis based purge calculations to understand MI related risk and control strategy options - Recording