Navigating Regulatory CMC Challenges Across Kit-Based & Ready-to-Use Radiopharmaceuticals: An Industry Perspective

• Comparing the distinct regulatory CMC considerations for kit-based and ready-to-use radiopharmaceuticals, spanning diagnostic and therapeutic applications and small to large vector approaches 
• Examining key challenges, opportunities and areas of ambiguity within the evolving radiopharmaceutical regulatory framework, highlighting where further clarity could enable more effective development strategies 
• Exploring industry perspectives on current regulatory expectations through practical, publicly available examples, identifying how different product formats are navigating CMC requirements in practice 
• Opening the discussion to explore the challenges raised during the presentations, enabling audience-led discussion and exchange on evolving regulatory CMC expectations

Including an interactive regulatory panel and audience Q&A.

Speakers:

Mark Fielding

Director - Chemistry, Manufacturing, Controls, Regulatory Affairs & Radiopharmaceuticals

AstraZeneca

Sandra Hennig

Senior RA CMC Strategist

Bayer

Anil Lalwani

Director - Regulatory Chemistry, Manufacturing, Controls & MedTech

Telix Pharmaceuticals