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Informa

12 - 13 September 2017
Clarion Congress Hotel,
Prague

Effective Genotoxic Impurity Identification Through Data Benchmarking, Innovative Tools and Successful Guideline Implementation

Implementation Strategies Across All Aspects of Genotoxic Impurity Assessment

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?

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

130+
Companies from the Pharmaceutical and Biopharmaceutical Industries
9/10
Top Global Pharmaceutical Companies
75:25
Buyer:Seller

Analyse, Interpret, Improve

A Pre-Conference Workshop Dedicated to Practically Implementing the ICH M7 Guideline
  • 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
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
Knowledge Exchange and Additional Evening Seminars
  • Thought Leaders Discussion Panels
  • Interactive Flash Presentations
  • Case Studies and Roundtable Discussions
  • Ask the Experts: Pain Points Discussions

Evening Seminars:

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.