Institute for International Research

• Regulatory Experiences: Hear current FDA and EU experiences to understand how to implement the EU Guidance
  
  • Dr. Roland Froetschl, Genetic Toxicology. Federal Institute for Drugs and Medical Devices, BfArM, Germany
• Toxicology: Tools to assess Genotoxic Impurities and interpret the results
• Analytical Chemistry/CMC: Understand the methods and techniques to analyze and contain low level of impurities
• Process Chemistry/Quality Assurance: How to avoid and get rid of Genotoxic Impurities

Prepare Now! Take this Opportunity to:

• Compare the PhRMA, ICH, and EU papers and guidance
• Hear strategies for navigating the FDA GTI processes
• Understand toxicological perspective of risk assessment
• Explore the concept of Threshold of Toxicological Concern (TTC) to learn how regulators and industry are tackling this challenge
• Discover analytical approaches and chemical processes for understanding GTIs
• Discuss a risk-based approach for controlling GTIs
• Learn the structure determination and assessment of GTIs from forced degradation products
• Gain new prediction tools of degradation pathways and GTIs