Archived: VIRTUAL TRAINING EVENT | Mutagenic Impurities the Impact of N-Nitrosamines

their management and current state of mutagenic impurity risk analysis

Date: 21 May - 22 May 2020

Location: Online Event

Tutors: Dr Andrew Teasdale

This is a VIRTUAL short course that will look at Mutagenic Impurities and the Impact of N-Nitrosamines and their management and current state of mutagenic impurity risk analysis.  The course will be in two sections of 3 hours each (with breaks) held over two consecutive days as follow:

May 21, 1.30 – 4.30 pm (UK)  |  Session 1


  • N-Nitrosamines – current regulations – their interpretation and impact
    • EMA + Q&A
    • Other authorities – similarities and differences
    • Pharmacopoeial requirements
    • Alignment to ICH M7
  • N-Nitrosamine risk assessment
    • Identification of key risk factors and current understanding
    • Purge calculations – can they be used for N-Nitrosamines?
    • Technical challenges
    • Role of safety assessments in silico and in vitro testing + interpretation of existing carcinogenicity data
  • Future expectations
    • Current scientific investigations and implications

May 22, 1.30 – 4.30 (UK) |  Session 2

Mutagenic Impurity Risk assessments – recent advances and their impact

  • What impact does the issues relating to N-Nitrosamines have on ICH M7 ?
    • How to conduct a systematic risk assessment
    • Consideration of side reactions
    • Control options – use of purge calculations to define control options
  • Safety Evaluation
    • In silico assessments – evolution of understanding
    • In vitro / in vivo testing – how to use Ames test and other safety data to evaluate risk, including latest knowledge relating to Boronic acids
  • Analysis of Mutagenic impurities
    • Systematic approaches
    • Orthogonal techniques
    • Overview of N-Nitrosamines testing – key lessons learnt

Mutagenic Impurity exercise

When you register you will be sent links to join the on-line sessions. These will take place at the following time each day:

1.30 – 4.30 pm  |  UK

2.30 – 5.30  |  Central Europe

08.30 – 11.30 |  Eastern US

5.30 – 8.30 am  |  West Coast US

As space is limited there is a small charge of £195.00 + VAT* per person (*only added if your company is based in the UK) Payments only available via credit card.


Virtual Delegate 2020

I really enjoyed the virtual Short Course and it was very good incl. the thorough collection of examples etc.

Looking forward to the next ones!