Ashley Mishoe
Vice President - Regulatory Affairs & Quality Assurance PharmaLogic
Seminars
Wednesday 30th July 2025
Built to Last: Creating a Quality-Driven, Collaborative CDMO Platform for Radiopharmaceutical Success
12:00 pm
- Comparing the regulatory frameworks of 21 CFR Part 211 and Part 212, emphasizing the key differences in compliance for radiopharmaceuticals
- Harmonizing drug sponsor and CDMO quality system expectations for PET diagnostics and therapeutics
- Leveraging CDMO regulatory experience to expedite sponsor submissions
- Exploring the relationship between quality, regulatory, and CMC for optimal drug development.Â
