Archived: NEW | N-Nitrosamine Mini-Event

Date: 14 June 2022

Time: 13.00 (BST), 14.00 (CEST), 8.00 (EST) - 18.00 (BST) GMT

This NEW free to attend webinar / Hopin mini-event sought to present the very latest in terms of N Nitrosamines, tracking the evolution of the issue through the regulations as well as looking at specific risk factors and the scientific investigations currently being undertaken to both better understand and contextualise the range of potential risk factors. Trying, where possible, to tease out what is risk and what is not.  In parallel it simultaneously looked at the latest advances in technology to support both research and risk assessment.

The Key Note Presentation:  was presented by Dr Andrew Teasdale, AstraZeneca.

“N-Nitrosamines – Current status of regulations and science”

Outline Program:

1.00       Event Opens – Visit the Sponsors / Exhibitors

2.00       Plenary Session / Key Note Speaker –  Dr Andrew Teasdale, Chair of AstraZeneca Impurities Advisory Group and Head of External Advocacy

3.30      Hosted Discussion Session – Lhasa  |  How can nitrosamine risk assessments be supported by in silico systems and data sharing initiatives?

4.00       Hosted Discussion Session – Waters  |  Technologies for Optimising Performance and Removing  Analytical Uncertainty in Trace Impurity Qualification

4.30       Hosted Discussion Session – ACD Labs  |  Using CMC Decision Support to Enhance Control Strategies

5.00      Visit the Sponsors / Exhibitors

6.00       End

We’d like to thank Lhasa, Waters, ACD Labs and AMPAC for their kind sponsorship.

About our Speaker:

Dr Andrew Teasdale is the author of over 50 pier reviewed scientific papers as well as three books:

  • ICH Quality Guidelines: An Implementation Guide,
  • Genotoxic Impurities: Strategies for Identification and Control (published originally in 2010, followed now by a much revised second edition:
  • Mutagenic Impurities: Strategies for Identification and Control, published February 2022.

Andrew is also tutor on the 2-day course: Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies.



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