Jennifer Eck
Senior Director, CMC Regulatory Affairs AstraZeneca
Seminars
Wednesday 5th November 2025
Analyzing ADC Regulatory CMC for the FDA & Beyond: What are the Best Strategies for Global Sponsor-Regulator Interactions?
2:00 pm
- Exploring strategy for ADC global accelerated regulatory submissions
- Assessing nuances between global regulatory bodies to best approach regulatory submissions and post approval changes
- Understanding optimal timing and approaches to undergo health authority meetings
