Cassandra Slader
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
Wednesday 21st October 2026
Managing Early Access Requests for Excluded or High Risk Populations
8:30 am
- Managing access requests for populations typically excluded from trials or standard programmes (e.g. pregnancy)
- Translating incomplete or indirect evidence into defensible access decisions without creating research like risk
- Balancing ethical pressure to act against safety uncertainty and lower monitoring intensity in access programmes
- Establishing internal guardrails for exception based access that stand up to scrutiny
