Honing Your Regulatory CMC Dossier Details Upfront & During Screening
Time: 9:00 am
day: Conference Day Two
Details:
- • 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
