VIRTUAL TRAINING EVENT | Mutagenic Impurities the Impact of N-Nitrosamines
Event overview
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
- 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.
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