ICH M7 applications for drug impurities and extractables & leachables
"The minicourse is very informative, tailormade based on the attendees knowledge and expectations.
Elena is very clear in explaining also complex concepts, giving the right level of details based on the request.
I found the minicourse very useful also for improving the quality of my own toxicological reports. I do recommend this course to experts and toxicologists which do not deal on daily basis with SAR predictions on genotoxicity"
— Claudia Cusan, Vice President,
S&C BEST srl
If you are interested solely in the aspect of computational toxicology covering the in silico assessment of potential mutagenicity for regulations such as ICH M7 for drug impurities and extractables and leachables, we are pleased to announce we are now offering a new stand-alone course.
3 hour course with a 15 minute break run in one session
Cost of course: £450 plus VAT
Maximum of up to 5 people per course
Course is provided at a mutually agreeable date
The course provides a good grounding for scientists and analytical chemists involved in silico assessment of mutagenicity for drug impurities / extractables and leachables under ICH M7.
In addition to the attendance on the live streaming, you receive a copy of the recording for your personal use and all the material related to the course. Finally, the trainer is available for a single 30 minute session that can be taken up to 3 months after the course ends to answer any course-related questions. A certificate of attendance is also available upon request.
Optimal involvement and interactions between the trainer and the trainees are ensured by limiting the number of attendees to 5 per class. The trainees are encouraged to interact, ask and answer questions with the other trainees and trainer.
The trainer, Dr. Elena Fioravanzo, is a qualified chemist and a well-recognized scientific investigator in computational chemistry and computational toxicology. She has more than 20 years of experience as a consultant and in providing training on approaches and on specific software.
If you want a broader course on in silico toxicology, we would recommend attendance on our 12.5 hour "New Approach Methodologies (NAMs) Application of QSAR and read-across" course which includes much of the material in this course.
In silico assessment for potential mutagencity
3 hours including a 15 minute break
What is a Rules-based (Q)SAR
What is a statistical-based (Q)SAR
Strengths and limits of (Q)SAR
Valid predictions and the OECD Principles
In silico assessments as per ICH M7
Free and commercial tools for Ames predictions
Practical examples will be demonstrated using freely available tools:
Danish QSAR Database / Models, EPA Dashboard, VEGA, OECD QSAR Toolbox, T.E.S.T., LAZAR
To ensure the quality of the training and to allow all the participants to meet their goals the number of attendees is limited to 20. Registrations will be accepted on a first come, first serve basis.
Session 1 - 2 hours - Searching for chemical data and evaluate structural similarity
Substance, chemical structure, identifiers
Molecular descriptors I
Practical examples will be demonstrated using: ChemSpider, OECD QSAR ToolBox, COSMOS DB, ChemTunes•ToxGPS©, AMBIT
At the end of this session you'll be able to:
Search chemical databases using a identifier, a chemical structure or a chemical substructure
Calculate molecular descriptors
Calculate structural similarity