Pre-Conference Workshop Day
Tuesday, September 23
8:00 am Check-In & Coffee
9:00 am – 12:00 pm | Workshop A
CMC Strategies for Bridging Early Development to Pivotal Trials in Radiopharmaceuticals
Synopsis
Advancing radiopharmaceuticals from early development into pivotal trials brings unique challenges that extend beyond traditional drug modalities. Compressed timelines, complex supply chains, and evolving regulatory expectations demand that critical technical and strategic choices are made earlier than ever before. Success depends on anticipating late-stage requirements while balancing the realities of early-phase development.
This workshop will bring together industry leaders to share insights, highlight lessons learned, and discuss strategies to de-risk the path to commercialization through:
• Comparing early- vs. late-phase drug product lifecycles and their clinical implications
• Applying Quality by Design principles to pivotal and commercial assets
• Navigating regulatory interactions and integrating CMC to ensure scalability
12:00 pm Lunch Break & Networking
1:00 pm – 4:00 pm | Workshop B
Addressing Unique Challenges in Radioactive Material Compliance to Harmonize Global cGMP Standards & Enhance Regulatory Confidence for Drug Approval
Synopsis
Navigating differing U.S. and European regulations is increasingly challenging. This workshop explores how regional GMP requirements affect manufacturing and supply chains, offering strategies to align compliance globally. Learn how early collaboration with regulators can speed up clinical supply approvals and international market entry.
Join this workshop to:
- Uncover the regulatory differences affecting manufacturing and supply chain across regions, particularly in Europe and the U.S.
- Discuss strategies to harmonize compliance practices for providing clinical supply, with a focus on how cGMP requirements for radiopharmaceuticals differ due to concerns around radiological safety, dose consistency, and product stability.
- Identify partnerships with regulatory experts to better navigate international approval processes.