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Track 9: Regulatory

This track is composed of sessions addressing global laws, regulations, guidelines, and guidances that govern prescription biopharmaceutical and device product development, approval, and maintenance. Representatives from various regulatory health authorities and agencies, and other regulatory experts will provide global updates, insights, and discussion on current issues through interactive forums. Themes commonly revolve around global regulatory changes and impact on global development strategies, global harmonization/convergence and impact on drug development, advances and innovations to improve the practice of regulatory affairs, and regulatory hot topics are always prominently featured.

DIA recommends this track and associated sessions to professionals involved in regulatory affairs and strategy, regulatory operations, regulatory information management, regulatory agencies, government affairs, legal affairs and compliance, policy and intelligence, clinical research and operations, pharmacovigilance, HTA (Health Technology Assessment), project management, and service providers developing tools and resources for use by sponsors and CROs.

Included Topic Areas

Regulatory affairs, regulatory policy, regulatory intelligence, regulatory strategy, global and US advertising and promotional regulations and laws; regulatory operation best practices, regulatory science, eSubmissions, regulatory document management; regulation pertaining to study endpoints, product labeling, biosimilars, combination products, advanced therapies (e.g., regenerative medicine, tissue products, gene therapy), companion diagnostics, devices.

Priority Topics

  • New Regulatory Programs and Recent Legislative Initiatives
  • Clinical Trial Innovation and Modernization
  • Artificial Intelligence
  • Diversity and Equity in Health Research
  • Real-World Data (RWD) and Real-World Evidence (RWE)
  • Cell and Gene Therapy, Vaccines, and Advanced New Modalities
  • Global Regulatory Collaboration and Harmonization
  • Combination Products
  • Benefit/Risk and Patient Focused Drug Development
  • Innovation in Inspections and Compliance
  • Expedited Programs
  • Diagnostics and Digital Therapeutics

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