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12 - 13 September 2017
Clarion Congress Hotel,

Efficient and accurate genotoxic impurity identification and control through data benchmarking and expert interpretation of ICH M7

Thank you to everyone who attended this year's Genotoxic Impurities


We would like to extend a very big thank you to everyone who attended this year's Genotoxic Impurities conference. In the heart of Berlin, analytical scientists, researchers, engineers and experts gathered to benchmark with the latest data and get expert interpretation of ICH M7 for more efficient and accurate genotoxic impurity identification and control.

The event delivered valuable insight into the current status of the ICH M7 addendum; Regulatory Authority expectations for successful genotoxic impurity identification and control; an update on the latest developments with the purge tool; advice on the use of a second in-silico tool under ICH M7 for GTI assessment, and practical guidance for the successful integration of a genotoxic impurity control strategy into a QbD framework. 

It was great seeing so many familiar faces, as well as meeting lots of new ones. 

Mark your calendar - The dates for our 2017 meeting have been released and we are delighted to announce that next year we will be in Prague at the Clarion Congress Hotel on 12-13 September 2017. We look forward to seeing you there.

FREE On-Demand Webinar: Practical implementation of ICH M7: Key successes and challenges so far

With ICH M7 now effective, ensure that you are applying the guideline effectively to your daily work and overcoming challenge and pitfalls. A clear understanding and application of the guideline is essential to ensure compliance and meet regulatory expectations.

  • Outlining how the final ICH M7 guideline is being apply to day-to-day work
  • Key advantages and successes experienced
  • Reviewing the challenges and pitfalls and how these have been overcome

Led by:

Andrew Teasdale, Principal Scientist, Chair of Impurity Advisory Group, AstraZeneca, UK



Implementation Strategies Across All Aspects of Genotoxic Impurity Assessment

The only European conference dedicted to ensuring ICH M7 compliance
  • Current status of the ICH M7 addendum: Calculation of compound-specific acceptable intakes - what is the impact on industry?
  • What are regulatory authority expectations for successful genotoxic impurity (GTI) identification and control?
  • Purge tool developments - what are the latest developments and regulatory authority opinions?
  • Use of a second in silico tool under ICH M7 for GTI assessment - what are the best strategies?
  • How can a genotoxic impurity control strategy be successfully integrated into a QbD framework?
Direct access to the top industry and regulatory speakers
  • Andrew Teasdale from AstraZeneca brings valuable insight on the ICH M7 addendum and latest developments of the purge tool
  • Feedback and suggestions for GTI submission improvements from the Norwegian Medicines Agency
  • ICH M7 in operation and lessons learnt from specification is discussed by Lutz Muller from Roche
  • Generics company perspective from Teva on best practices for genotoxic impurity identification and control
  • 16 practical experience case studies to allow benchmarking of techniques
All access at no additional cost to other events at Genotoxic Impurities

Aside from genotoxic impurities, benefit from additional learning opportunities at the same venue, on the same dates with conferences looking at:

Network with 350+ toxicology, analytical, quality and formulation decision makers

Companies from the Pharmaceutical and Biopharmaceutical Industries
Top Global Pharmaceutical Companies

Analyse, Interpret, Improve

Knowledge Exchange
  • Thought Leaders Discussion Panels 
  • Interactive Flash Presentations
  • Case Studies and Roundtable Discussions
  • Ask the Experts: Pain Points Discussions
Peer to Peer Networking & Partnering Opportunities
  • Event App: Browse the delegate list, access speaker presentations, set up 1-to-1 meetings, view the latest agenda and vote on industry hot topics 
  • Drinks Reception and Social Evening
  • Informa Treasure Hunt
  • 5 Conferences in 1 Location
Focus Days and Additional Seminars

Pre-Conference Workshop:

  • Elemental Impurities and ICH Q3D Focus Day

Evening Seminar, Discussion and Dinner: 

  • Overcoming Challenges with Genotoxic Impurity Testing in Starting Materials

Associate Sponsor

Pharmaceutical Training International | PTI

PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We deliver CPD certified training on a wide range of topics including R&D, pre-clinical, clinical, manufacturing, regulatory affairs, pharmacovigilance, biotech, business strategy and soft skills. Our courses are delivered in a variety of formats such as public face-to-face, customised in-house, webinars, eBooks and online academies.