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Walter E. Washington Convention Center

Jun 15, 2025 7:15 AM - Jun 15, 2025 5:45 PM

801 Allen Y. Lew Place, NW, Washington, DC 20001-3614, USA

Global Regulatory Harmonization and Improving Access to Advanced Therapies Summit

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Overview

June 15: Summit

Join us in facilitating multi-stakeholder dialogue, accelerating transformative changes, collaboratively identifying the barriers obstructing progress, and charting the best path forward in global harmonization in regulations for the development of cell and gene therapies. DIA held a multi-stakeholder executive roundtable in January 2024 on this topic and is excited to invite the broader community from academia, government, industry and nonprofit organizations to join us in June. Together, we’ll unravel the potential and address the hurdles of this dynamic frontier in regulatory science and come up with an action plan and recommendations, which we plan to report on during the DIA Global Annual Meeting, scheduled to start June 16, 2025.

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Highlights & Features

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Who should attend?

  • Conference Designed for

    • Academia
    • Biotechnology
    • Clinical Pharmacology
    • Clinical Research and Development
    • Clinical Operations
    • CMC
    • CROs/Vendors
    • Drug Discovery
    • Drug Safety/Pharmacovigilance
    • Government Affairs
    • Policy and Intelligence
    • Preclinical
    • Quality Assurance
    • Regulatory Agencies
    • Regulatory Affairs, Operations, and Strategy
    • Research and Development
    • Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
    • Strategic Sourcing/Planning

    Learning objectives

    • At the completion of this conference, the participant should be able to:

      • Understand the latest advancements in cell and gene therapy, including the journey from research to patient access
      • Explore challenges in global regulatory harmonization and strategies to align regulatory requirements across different regions
      • Analyze case studies from leading companies to identify practical lessons and opportunities in oncology, rare disorders, and blood disorders
      • Engage in multi-stakeholder dialogues to craft actionable recommendations for regulatory and clinical advancements in advanced therapies

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