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Nitrosamine | Webinar

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)

Speakers:

Eduardo Rodenas

Eduardo Rodenas

Chief Scientific Officer

Ana María Sanz

Ana María Castro

Toxicology Responsible

Javier Fernández

Javier Fernández

Toxicology Officer

  • 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.

Webinar content

  • INTRODUCTION
  • 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
    d. Examples
  • Q&A

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

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