This session explores how to prepare data for AI and regulatory expectations through interoperable architectures with HL7 FHIR. Attendees will discuss how to make their own data reusable, trustworthy, and ready for tomorrow’s regulatory requirements.
Learning Objectives
• Show how the life sciences industry is using modern technology and HL7 FHIR to break down data silos. • Demonstrate how interoperable data becomes “AI ready” and “Health Authority ready.” • Engage participants in discussing practical steps for improving data quality, structure, and trust.
Principal Consultant, Epista Life Science, United States
Joan Cheung is a Senior Consultant at Epista Life Science where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs... Read More →
Monday June 15, 2026 12:50pm - 1:20pm EDT Content HubThe Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products
Learning Objectives
Benchmark key drivers for assessing supply- and demand-related risks that may lead to drug shortages. Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products. Apply risk-based decision making to strengthen global supply continuity and regulatory compliance.
Monday June 15, 2026 1:30pm - 2:00pm EDT Content HubThe Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
This session covers the importance of representative enrollment in Phase 3 Lupus trials, Biogen’s approach to setting and achieving these goals, and how patient-focused strategies improve clinical trial integrity and outcomes.
Learning Objectives
1. Understand the key challenges in representative enrollment in Phase 3 Lupus clinical trials. 2. Learn how Biogen approached setting enrollment goals that reflect the epidemiology of the disease and specific strategies developed and initiatives executed to achieve these goals. 3. Understand the importance of representative enrollment on trial outcomes and patient care and how this is achievable
Tuesday June 16, 2026 11:40am - 12:10pm EDT Content HubThe Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
This session will explore how regulatory system strengthening and harmonization can act as a catalyst for regional pharmaceutical manufacturing in Africa, ensuring access to quality-assured medicines and building a resilient health ecosystem.
Learning Objectives
1. Discuss the role of regional regulatory harmonization initiatives in reducing duplication, and improving patient access 2. Examine how collaboration between manufacturers and regulators can streamline product development, improve compliance, and reduce time-to-market for essential medicines 3. Share lessons learned to inform future efforts and actions to support supply chain resilience
Wednesday June 17, 2026 11:40am - 12:10pm EDT Content HubThe Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
What if protocols weren’t documents - but executable trial blueprints? Learn how protocol digitization into structured USDM content, combined with clinical operational data, enables orchestration across systems to streamline and improve trials.
Learning Objectives
Identify how digital protocols and structured USDM models improve clinical operations and accelerate trial timelines through ecosystem orchestration. Evaluate how site operational data generates insights that streamline execution and improve protocol design. Learn how industry peers are approaching protocol digitization, including key challenges and lessons learned.
Wednesday June 17, 2026 12:20pm - 12:50pm EDT Content HubThe Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
