Regulatory

Regulatory

  • Regulatory challenges for  new vaccine modalities and emerging technologies
  • Overcoming IP and regulatory hurdles for RNA vaccines
  • Working towards platform pre-qualification
  • Regulatory convergence – the prospect of global regulatory submissions
  • Regulatory implications of computational tools (e.g., modeling and digital twins) in vaccine CMC
  • How can regulatory frameworks support sustainability?
  • How will therapeutic cancer vaccines be codified in current regulatory frameworks?
  • Implications of new guidance e.g., EMA’s 'Guideline on the quality aspects of mRNA vaccines'
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