Understanding QP Certification in Early Access: Legal Triggers, Country Variation & QP Responsibilities
Time: 4:00 pm
day: Day 2
Details:
• Differentiating QP requirements across early access types, including compassionate use, named patient programmes, and cohort-based schemes
• Navigating fragmented EU and UK expectations for QP release in non-commercial product settings
• Clarifying QP responsibilities for oversight, documentation, and compliance amid diverse regulatory interpretations
