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DIA 2027 · San Diego, CA

Track 8: Regulatory Policy, Strategy and Global Collaboration

This track explores the evolving global regulatory environment by bringing together regulators, industry, and other stakeholders to examine the laws, regulations, guidelines, and frameworks that shape the development, approval, and lifecycle management of drugs, biologics, medical devices, and combination products. Sessions highlight innovative regulatory strategies, evidence generation, regulatory modernization, accelerated development pathways, global convergence and reliance initiatives, regulatory operations, and collaborative approaches that advance timely patient access to safe and effective therapies. Participants will explore current and emerging regulatory policies, regulatory intelligence, digital and AI-enabled approaches, patient-focused drug development, and best practices that strengthen regulatory decision-making across the product lifecycle.

Themes
  • 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, inspection and compliance innovations, policy implementation, and measuring regulatory impact
  • Evidence Generation, Patient-Centricity & Emerging Paradigms: Approaches for generating, integrating, and applying evidence, including DHTs, digitally derived endpoints, biomarkers, patient experience data, RWE, AI/ML, and decentralized trials, to support benefit-risk evaluation and regulatory decisions across the product lifecycle
  • Regulatory Applications of Innovative Approaches: Strategies, frameworks, and case examples for applying innovative scientific and technological tools, including model-informed drug development (MIDD), new approach methodologies (NAMs), DHTs, novel endpoints approaches, RWE, and AI/ML across regulatory review, decision-making, and oversight
  • Regulatory Intelligence & Strategy: Best practices, frameworks, and case examples for navigating complex global regulatory requirements, submissions, and labeling, including leveraging AI to inform regulatory strategy, labeling analysis and negotiation, competitive intelligence, regulatory landscape mapping, and proactive health authority engagement
  • Reliance Pathways, Work-sharing, and International Collaboration: Promoting regulatory convergence, reliance, efficiency, and timely availability of medicines
  • Accelerated Development Pathways: Expedited regulatory pathways, innovative trial designs, and development frameworks for unmet medical needs and special populations
  • Regulatory Operations Excellence: Strategies, digital 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, ATMPs, and combination products
  • Ensuring Global Access to Medicines: Regulatory, policy and collaborative approaches to improve global access to medical products, including payer and coverage decisions, evolving legislative frameworks, and regulatory strategies that influence availability and access. Manufacturing continuity and operational supply chain considerations are addressed in Track 7.
Key Questions to be Addressed
  1. How is the global regulatory landscape evolving, and what strategies can help organizations navigate increasing complexity while advancing regulatory convergence, reliance, efficiency, and timely access to medicines?
  2. What regulatory innovations, modernization efforts, and operational approaches can improve regulatory review, submissions, compliance, and decision-making across the product lifecycle?
  3. How can organizations generate, integrate, and apply innovative sources of evidence, including RWD, AI/ML, digital health technologies, biomarkers, and patient experience data, to support regulatory decisions and product development?
  4. How are regulators and industry advancing accelerated development pathways, innovative technologies, and regulatory strategies to address unmet medical needs, special populations, and emerging therapeutic modalities?
  5. What regulatory intelligence, strategic planning, and health authority engagement approaches can help organizations make informed decisions, navigate global regulatory requirements, and avoid compliance risks?

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