TOPIC 5: REGULATORY GUIDANCE ON ONCOLOGY DRUG DEVELOPMENT
Update on the Revision of EMA Anti-Cancer Guideline & Regulatory Science Strategy 2025:
Sigrid Klaar (Swedish Medical Products Agency, SE) & Ralf Herold (EMA, NL)
FDA Guidelines – Richard Pazdur (FDA, US)
Industry Aspect – Eric Rubin (Merck, US)