Donna Supko
Vice President Regulatory Affairs RadioPharm Theranostics
Seminars
Thursday 31st July 2025
Regulatory Perspectives for Radiopharmaceuticals from Diagnostics, Theranostics & Therapeutics
3:30 pm
• Exploring key regulatory considerations for the development and marketing authorization of radiopharmaceuticals
• Touching on product type and target label claims, with a focus on the US regulatory landscape
• Uncovering future perspectives and initiatives for radiopharmaceutical regulatory affairs
Thursday 31st July 2025
Panel Discussion: Promoting Regulatory Harmonization for Radiopharmaceutical Clinical Research
4:00 pm
• Discussing EMA’s concept paper and FDA’s project optimus
• Exploring how the field can harmonize regulations to streamline development
