Virtual Training Event - Mutagenic Impurities the Impact of N-Nitrosamines

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 + QandA
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 if based in the UK, other countries will be out of scope) Payments only available via credit card.

Others Details

URL: Brochure: https://go.evvnt.com/642618-2?pid=6581 Category: Community | Virtual Event Artist / Speaker: Dr Andrew Teasdale Time: 09:00 to 17:00