This track provides a comprehensive view of the evolving global regulatory environment, bringing together regulators, industry, and other stakeholders to explore laws, regulations, guidelines, and frameworks that shape drug, biologic, device, and combination product development, approval, and lifecycle management. Sessions highlight innovative approaches to regulatory strategy, modernization of review processes, global convergence and reliance initiatives, and collaborative pathways to accelerate patient access to safe and effective therapies.
Through interactive discussions, participants will gain insight into current and emerging regulatory policies, best practices for regulatory operations, and the role of patient-focused drug development in shaping regulatory decision-making globally.
Themes:
- Global Regulatory Harmonization and Collaboration: Harmonization, reliance, and convergence initiatives, plus cross-agency partnerships (e.g., Project Orbis) to streamline development timelines, market access, and post-market changes
- New Regulatory Programs and Recent Legislative Initiatives: Preparing for and responding to emerging regulatory programs, legislative changes, and policy priorities shaping global drug development and oversight
- Health Authority Modernization: New review paradigms, innovative regulatory frameworks, and inspection/compliance innovations
- Regulatory Applications of AI: Approaches, frameworks, and case examples for applying AI in regulatory review, decision-making, compliance, and oversight
- Regulatory Intelligence and Strategy: Best practices for navigating complex global requirements, submissions, and labeling.
- Diagnostics and Digital Health: Regulations governing companion diagnostics, medical devices, and digital tools.
- Accelerated Development Pathways: Expedited review programs, innovative trial designs, and frameworks for unmet medical needs and special populations.
- Regulatory Operations Excellence: Strategies, tools, and best practices to optimize end-to-end regulatory operations, including submission planning and management, global dossier lifecycle management, labeling operations, and alignment with evolving regulatory requirements and technologies
- Special Populations in Health Research and Product Development: Regulatory considerations for rare diseases, pediatrics, chronic conditions. gene therapy, vaccines, and ATMPs, and combination products
- Benefit-Risk and Patient-Focused Drug Development: Incorporating patient perspectives and real-world evidence into regulatory decision-making
- Ensuring Global Access to Medicines: Regulatory, policy and collaborative approaches to prevent and address drug shortages. Emphasis on payer and coverage decisions (e.g., CMS' National Coverage Determination for Alzheimer’s Disease), and evolving legislative frameworks (e.g., EU’s General Pharmaceutical Legislation, joint EMA HTA assessment) that shape availability and access, with manufacturing continuity and operational supply chain challenges addressed in Track 7.
Key Questions to be Addressed:
- How can we optimize our global regulatory strategies to navigate evolving laws, reliance frameworks, and cross-agency collaborations to achieve faster approvals and broader market access?
- What are the latest regulatory innovations and modernization efforts (AI-assisted reviews, new inspection paradigms, digital health oversight) that can help reduce time, cost, and risk in bringing therapies to patients?
- How are agencies approaching accelerated pathways, advanced modalities, and patient-focused drug development, and what can companies do to position their products for expedited, successful reviews worldwide?
- What are the key regulatory intelligence insights (policy changes, advertising and promotion trends, diagnostics regulation) that can help teams make better strategic decisions and avoid compliance pitfalls globally?
