Regulatory Feasibility of Post-Trial Access: Meeting Legal & Ethical Obligations
Time: 11:00 am
day: Day 1
Details:
• Clarifying EU-specific regulatory expectations and legal requirements for post-trial access across member states
• Evaluating feasibility and compliance challenges under GDPR, national regulations, and EMA guidance
• Addressing ethical responsibilities and patient care obligations in the absence of harmonised EU-wide post-trial access policies
