PDA Europe Webinar - The Chemistry of Nitrosamines – Implications for Risk Assessment

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Chemistry and Risk Assessment of N-nitrosamines with Focus on Drug Product and Elastomeric Primary Packaging Components

Dear Colleagues,

Since their discovery in June 2018, nitrosamines have received a lot of attention amongst global pharmaceutical industry. Recent decisions from regulatory bodies involve the development of a risk assessment and a possible reduction and control of nitrosamines in the final drug product by the marketing authorization holder. Now, we have all been allowed extra time for the preparation of the risk assessment for the EDQM. But still, this topic is quite complex and there are several open questions.

In this webinar, we want to address some of the open questions, for example, how can we account for the specific chemistry of nitrosamines in the risk assessment and how play elastomeric components a role here?

This and more will be covered both from the perspectives of a pharmaceutical company as well as a rubber component supplier.

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WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Welcome & Introductions

Introduction to Nitrosamines:
General Information and Current Regulatory Updates

Bettine Boltres, WEST

A Pharmaceutical Perspective:

  • Insights into the chemistry of nitrosamines
  • Focus on the drug product over the shelf-life
  • Implications for risk assessments
Steve Baertschi, Consultant

An Elastomeric Primary Packaging Perspective:

  • General composition & vulcanization
  • Raw materials and their potential connection to nitrosamines or their precursors
  • General nitrosamines analytics
  • Nitrosamine analytics on elastomer components
Bettine Boltres, WEST
How to Utilize Risk Assessment based on Components Results Steve Baertschi, Consultant
Interactive Live Q&A and Discussion

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