Honing Your Regulatory CMC Dossier Details Upfront & During Screening

Time: 9:00 am
day: Conference Day Two


  • • Streamlining regulatory submission process by strategically refining CMC dossier contents upfront
  • Elevating safety measures and risk assessments in gene therapy manufacturing including both product and process related impurities
  • Discussing practical approaches to seamlessly integrate comparability studies into the CMC dossier