The presence of nitrosamine impurities, probable human carcinogens, has presented significant challenges to the pharmaceutical industry since 2018, when N-nitrosodimethylamine (NDMA) was first detected in blood pressure medications like sartans. In response, both regulators and manufacturers have been actively working to identify, mitigate, and control these impurities in drug products.
The "Nitrosamine contamination" workshop will address these challenges, offering an overview of the latest developments, regulatory guidelines, and analytical approaches related to nitrosamine impurities. This webinar is designed for pharmacy and chemistry students, as well as professionals across the pharmaceutical industry, including those involved in regulatory affairs, manufacturing, and analytical testing. Experts from Apotex Canada, TGA and a leading Analytical equipment manufacturer will share their experiences in working with regulators and industry stakeholders to analyse nitrosamines and improve risk management strategies.
Program
12.00 - 12.10 - Chair welcome and introduction
Scott Colbourne
12:10 - 13.00 - Nitrosamines Contamination – What is the problem and how can we avoid and control it?
Dr Martin Ehlert, Vice President, Global API R&D Apotex Inc. Canada
13:00 - 14.00 - a. How the TGA is assessing medicines for Nitrosamines
b. Safety aspects of nitrosamines and determination of safety limits
Irene Horne & Daniel Truong, Medicines Regulation Division - TGA
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14:00 – 14.30 - How do we analyse Nitrosamines?
Speaker to be confirmed.
14.30 – 15.00 - Q + A
Event Terms & Conditions
Cancellation Policy A applies to this event. For full details, view our Cancellation Policy. By registering for this event, you agree to, and will be bound by, the RACI Event Terms and Conditions and Event Code of Conduct.
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