Webinar: Nitrosamine Impurities - Optimizing the risk assessment
January 30th (Thursday); Starting at 16:00 CEST (Spain)
Duration: 60 minutes (Attendance is free, advanced online registration may be completed below)
Chief Scientific Officer
Ana María Castro
- The FDA and EMA are providing marketing authorization holders with guidance on how to avoid the risk of detecting the presence of nitrosamine impurities. Therefore, as it is necessary to test all products which are at risk, MHAs have to conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-) contamination. Depending on the outcomes of this risk assessment, confirmation testing and even a change to the manufacturing process may be required.
- In this webinar, we will review the key aspects related to Nitrosamine impurities whilst putting emphasis on the more urgent issue: the risk assessment. Our experts will share essential information on how to handle this task so as to optimize time and resources and, of course, guarantee compliance with EMA requirements.
- AN OVERVIEW OF THE NITROSAMINE SCENARIO: TECHNICAL AND REGULATORY BACKGROUND
- RISK ASSESSMENT - OPTIMAL APPROACH
a. How to prioritize
b. Key issues in report development
c. Handling setbacks