Establishing Early Access Programs for Controlled Substances: Navigating Regulatory, Operational & Stakeholder Complexity

• Understanding the additional regulatory requirements and approvals required when setting up Expanded Access Programs for controlled substances
• Building internal processes and governance models that support compliance while maintaining timely patient access
• Coordinating effectively across Medical, Regulatory, Clinical Operations, Supply Chain, and Quality teams
• Lessons learned from launching and operationalizing controlled substance access programs, including common challenges and practical solutions

Speakers:

Tarolyn Carlton

Executive Director, Late-Stage Clinical Strategy

Definium Therapeutics