Genotoxic Impurities must be detected, identified, and reported before clinical trial initiation to ensure patient safety and eventual drug approval, but every drug and process has a unique set of process impurities. To ensure drug approval, the industry has heavily invested resources to address the GTI concerns and stay compliant with limits of genotoxic and potential genotoxic impurities.
IIR's GTI seminar is the only US intensive day and a half event that brings together industry thought leaders, genotoxic carcenogenic white paper and FDA guidance authors to define regulatory concerns, build industry best practices, and reduce the need for individual judgment calls. This intensive format designed for you to walk away with a toolkit including everything you need to know about GTIs such as FDA and EU regulatory clarification, toxicology tools to assess GTI's, best practices in determining degradation products,validation criteria for low level impurities, and much, much more.Join the event that is building industry best practices for assessing GTI's, specifically focused on process chemistry, stress testing, regulatory concerns and analytical chemistry
- Make sure your investment in resources to address GTI concerns are worth it, stay up-to-date with industry trends for limits of genotoxic and potential genotoxic impurities.
- Ensure patient safety, clinical initiation and drug approval by learning to detect, identify, and report Genotoxic Impurities
- Nothing can replace face to face time with industry peers. This event fosters brainstorming and idea exchange through interactive formats
- Hear Current industry thought leaders discuss the validity of the current TTC Limit, where do you stand on the debate? Is the level of conservatism in the TTC approach too high for your drug to be allowed into clinical development?
|Case Studies to Help You Manage GTIs|
- Reading Between the Lines - Experts Clarify the Gray Areas in the Regulations
Fenghe Qiu, Principal Scientist and Leader of the Trace Analysis Group, BOEHRINGERINGELHEIM
- Risk Assessment Tools for Potentially Genotoxic Human Metabolites
Yong Chen, PhD, Director, Analytical Chemistry & Scientific Compliance GPRD Development Sciences, ABBOTT
- Development of LCMS Methods for Genotoxic Impurities
Zhanna Yuabova, PhD, Analytical Sciences, BOEHRINGER INGELHEIM
- Implementing a Team Approachto Ensure Compliance in Global GTi Processes
Edgar Nicolas, Senior Director, Global Analytical Sciences Global Coordinator GTIs, SANOFI-AVENTIS