Nitrosamine Impurities MasterClass - EU edition

Various nitrosamines (such as NDMA, NDEA, and others) have been detected in nearly every drug product containing a sartan derivative as an API. An EMA Questions & Answers document describes various potential sources of nitrosamine contamination.

12-13 May, 2025, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

Various nitrosamines (such as NDMA, NDEA, and others) have been detected in nearly every drug product containing a sartan derivative as an API. An EMA Questions & Answers document describes various potential sources of nitrosamine contamination. In September 2019, the EMA published a press release advising pharmaceutical companies on steps to avoid nitrosamines in human medicines. In another document released around the same time, marketing authorization holders were requested to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesized APIs. Consequently, in cases of contamination with nitrosamines, marketing authorization holders are required to file a variation application.

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WHO SHOULD ATTEND

This live online training is aimed at all personnel involved in the development of drug substances and drug products, from scientific staff to laboratory heads in research and development. The needs of laboratory managers, supervisors, and analysts in pharmaceutical quality assurance and quality control departments will also be addressed. Furthermore, this training will cover regulatory requirements, making it applicable to individuals working in regulatory affairs.