Insights from Regulator Queries: Contextualising Regulatory Expectations for ADCs Across Global Markets with a Clinical Focus

• Leveraging agency feedback focusing on clinical submissions, highly relevant for sponsors navigating evolving requirements for ADCs
• Providing case examples of successful navigation or challenge resolution in early-phase ADC  CMC filings
• Breaking down takeaways from case study analyses to aid sponsor interpretation and application of global regulatory standards for ADCs

Speakers:

Guzin Sahan

Associate Director, Regulatory Affairs CMC

AstraZeneca