Annie Drelles
Global Senior Director, Office of Medical Access, Oncology Medical Affairs Daiichi Sankyo
Seminars
Monday 19th October 2026
Workshop E – Operationalising Informed Consent & Physician Led Responsibilities Outside Clinical Trials
11:30 am
- Defining what “informed consent” means in treatment focused access programmes rather than research settings
- Clarifying where sponsor responsibility ends and physician responsibility begins in non GCP environments
- Managing variability in how consent is obtained, explained, documented, and revisited over time
- Establishing defensible guardrails to support physicians without crossing compliance or promotional boundaries
