Mark Fielding
Director - Chemistry, Manufacturing, Controls, Regulatory Affairs & Radiopharmaceuticals AstraZeneca
I have a PhD in organic chemistry and joined AstraZeneca as a drug substance process development lead for synthetic pharmaceuticals. Following this, I moved into regulatory CMC and have since had oncology project lead roles covering the entire project lifecycle. More recently I have played a lead role in the regulatory CMC development of radiopharmaceuticals within AstraZeneca and am active in external trade associations, to help shape external guidance in this field.
Seminars
Wednesday 2nd December 2026
Navigating Regulatory CMC Challenges Across Kit-Based & Ready-to-Use Radiopharmaceuticals: An Industry Perspective
8:20 am
- 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.
