Monday, September 14, 2009

IIR's Genotoxic Impurities Brochure Ready to Download

IIR’s Genotoxic Impurities is the US event presenting New Toxicology and Analytical Chemistry Approaches for Managing Genotoxic Impurities (GTIs) in Compliance with EU and FDA Guidance. Click here to download the conference brochure.

IIR’s Genotoxic Impurities event is the only US intensive day and a half event that brings together industry thought leaders, white paper and FDA guidance authors to define regulatory concerns to build industry best practices to reduce the need for individual judgment calls. This intensive format designed to deliver everything you need to know about GTIs through regulatory case studies, interactive panel discussions and in depth round tables to build industry best practices.

Answers to Your Current GTI Questions
  • Identify what constitutes an Serious Adverse Reaction (SAR) alert
  • Strategies to assessing and handling degradation products
  • Discover sensitive analytical techniques that can provide accurate measurements of the genotoxic impurities in presence of the difficult matrices (API, lipid formulations and etc.)
  • Understand how other companies are handling issues such as related substances and degradation products
  • Define the appropriate scenario for running in silico and test in Ames
  • Determine how much and when to perform potential genotoxic impurities (PGI) fate mapping
  • Discussion on approaches to cumulative control of multiple impurities
Featured Sessions
  • FDA's Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products
  • PhRMA ATG GTI Working Group Update & Industry Survey Results!
Nancy Benz Project Leader, Process Analytical Chemistry, GPRD ABBOTT
PhRMA ATG GTI Working Group

We look forward to seeing you in Princeton, NJ.

P.S. Register and Save $200 off the standard registration by using VIP Code: 0TB3WA

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