Workshop E – Operationalising Informed Consent & Physician Led Responsibilities Outside Clinical Trials

• 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

Speakers:

Cassandra Slader

Global Head, Managed Access Programs

UCB

Annie Drelles

Global Senior Director, Office of Medical Access, Oncology Medical Affairs

Daiichi Sankyo