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

Donna Supko