Dawn Spiller
Senior Director CMC Regulatory Affairs AstraZeneca
Seminars
Join this closing panel session with your expert ADC CMC speakers to break down the key learnings from the seminar day. Listen and engage with your fellow attendees as they discuss and best approaches to maintain DS and DP stability, streamline process scale up and tech transfer, and debate opportunities for science-based justifications be applied to support alternative control strategies
- ADC regulatory submissions under accelerated timelines: Is it clear what is must have versus nice to have?
- Comparing ADC regulatory CMC guidelines across global Health authorities
- Assessing prioritizations for future industry-regulator interactions and science-based justifications for alternative control strategies
In fast-paced ADC development, optimizing scale-up, tech transfer, and setting specifications are all vital to assure confidence in regulatory submissions.
Attend this late-stage manufacturing seminar day to understand ADC regulatory CMC strategy, review opportunities to streamline CMC under ADC development timelines, and explore insights to improve ADC DS and DP manufacturing and stability in late-stage and post approval stages
Download the Full Event Guide for full details
