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23 - 25 October 2018
Hotel Palace Berlin,

Transform your genotoxic impurity identification

Thank you to everyone who attended in 2017.

Data benchmarking. Innovative tools. Guideline implementation.

2017 Agenda Highlights

Next Generation Analytical Techniques to Reduce Genotoxic Risk
  • Practical approaches to improve your analytical techniques
  • What is needed to implement new analytical techniques into a commercial system?
  • How can previous data be used to predict future Genotoxic Impurities?
  • What new technology is currently being used to successfully predict Genotoxic Impurities
Regulatory Assistance and Guideline Support for Successful ICH implementation
  • What are the necessary standards that must be met to ensure regulatory approval?
  • How do you approach the production of risk assessments and monographs for regulatory success?
  • What do the regulatory bodies seek within genotoxic data?
  • How to address the guidelines in a commercial stream.
Innovative Qualification Practises and Technology for Successful Genotoxic Extraction
  • What can techniques, such as Mass Spectrometry, do for Genotoxic Removal?
  • What is the effect of extractables and leachables on the Threshold of Toxicological Concern (TTC)?
  • How is the TTC used and defined within a toxicological framework?
  • What are the current toxicological concerns?


companies joined in 2016 – this year WILL be even bigger and better
top global pharma companies – are you the missing one?

Analyse. Interpret. Improve.

Practical implementation of the ICH M7 guideline workshop
  • Current status of the ICH M7 addendum: Calculation of compound-specific acceptable intakes - what is the impact on industry?
  • Addressing the Guidelines at a commercial level
  • How to address reporting on Genotoxic Impurities using the Threshold of Toxicological Concern
  • Current status of the ICH M7 addendum: Calculation of compound-specific acceptable intakes - what is the impact on industry?
  • Stages involved in a mutagenic risk assessment
New connections – the number 1 place for analytical networking
  • Event App - Browse the delegate list, access speaker presentations, set up 1-2-1 meetings, view the latest agenda and vote on industry hot topics.
  • Drinks reception - Our evening drinks reception offers the ultimate opportunity to swap top tips and business cards, as well as catch up with your peers in a more informal setting. And we will add food and entertainment to the mix to make sure you're not running on empty.
  • 4 streams in one location - Mix with the industry's leading experts working in both biological and pharmaceutical analytics.
Push the boundaries of your knowledge
  • Thought leader discussion panels
  • Interactive Flash Presentations
  • Case studies and roundtable discussions
  • Ask the Experts: Pain points discussions

Evening Seminars:

Promotional Participants