Anil Lalwani
Director - Regulatory Chemistry, Manufacturing, Controls & MedTech Telix Pharmaceuticals
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.
