Navigating Regulatory Requirements for Immunogenicity

The Draft 2016 Immunogenicity Guidance may not be final, but even its preliminary changes may affect your development program. Join our webinar to learn the best ways to plan your immunogenicity assessments during the preclinical and clinical phases of development.

We’ll help you prepare for regulatory compliance by explaining:

  • The difference in validation and data sets for each phase of your program
  • Expectations for clinical validations in light of the draft guidance
  • Strategies to re-validate assays to ensure successful submissions

Presenter

  • Jenifer Vija, PhD, Senior Director, Bioanalysis, Charles River