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Azierta webinars

Nitrosamine impurities: present, past and future

October 27th (Tuesday); Starting at 3:30 PM CEST (Spain)

Duration: 60 minutes (Attendance is free, advanced online registration may be completed below)

Ana María Castro

Ana María Castro 

Industrial Area Manager

Javier Fernández

Javier Fernández

Senior Toxicology Officer

  • FDA and EMA are providing Marketing Authorization Holders guidance on how to control the presence of Nitrosamine impurities. It is necessary to test all product at risk, thus MAHs 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 it might be necessary to perform confirmation tests and even change the manufacturing process. New deadlines have been agreed for the first step, risk evaluation: 31st March 2021 for chemical medicines and 1st July 2021 for biological medicines.
  • In this webinar, we will make a complete review of key aspects regarding Nitrosamine impurities, emphasizing the strategy for the control and surveillance of these compounds that must be defined by pharmaceutical laboratories. Our experts will share essential information about what they have learned during this time and about the challenges faced, their expectations of the regulatory agencies and how to handle biological medicines that now are also considered.

Webinar Content

  1. Introduction
  2. Nitrosamines scenario overview
  3. Risk assessment optimal approach and next steps
  4. New deadlines & How to face Biological medicines 
  5. Lessons learned
  6. Analytical approach
  7. Q&A

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