Caitlyn Harvey

Company: Convergent Therapeutics

Job title: Vice President, Head of CMC

Seminars:

Navigating the Transition from 21 CFR 212 to 210/211 Compliance in Radiopharmaceutical Manufacturing 9:30 am

• Key differences and gaps between 21 CFR 212 and 210/211 • Impact on CDMO/CMO facilities • Considerations for radiopharmacies and compounding pharmaciesRead more

day: Conference Day Two

Extended Roundtable: Practical Strategies for Compliance Transition 10:00 am

• What are the biggest hurdles in moving from 21 CFR 212 to 210/211 compliance, and how can they be addressed? • How are CDMOs/CMOs adapting their facilities and operations to meet late-phase and commercial needs? • What role should radiopharmacies and compounding pharmacies play as products transition to broader commercialization?Read more

day: Conference Day Two

CMC Strategies for Bridging Early Development to Pivotal Trials in Radiopharmaceuticals 9:05 am

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…Read more

day: Pre-Conference Workshop Day