Cell and Gene Regulatory

  1. Integration Challenges Between Manufacturing Systems And Quality Management 9/9/2025

    Disconnected systems are a leading cause of data integrity violations, which account for over 70% of FDA warning letters globally. Learn why integration is essential for compliance and operational success.

  2. Streamlining Compliance With AI-Powered Regulatory Intelligence 9/9/2025

    Life sciences compliance is complex and ever-changing. Discover how modern solutions can streamline processes, reduce friction, and keep your organization ahead of regulatory demands.

  3. ATMP Development In 2025: Promise, Pressure, And The Push To Scale 9/9/2025

    Drive the next wave of cell and gene therapy innovation by overcoming operational, funding, and regulatory challenges to deliver life-changing treatments to patients faster.

  4. GLP-1 Ocular Safety Monitoring At Point-Of-Need 9/8/2025

    Regulators are sharpening their focus on ocular safety in GLP-1 receptor agonist trials following emerging evidence linking semaglutide to non-arteritic anterior ischemic optic neuropathy (NAION).

  5. Cell And Gene Therapy In Conversation 9/8/2025

    Industry experts share strategies to overcome key barriers in CGT development, from reproducibility to scale-up. Gain practical insights to help teams move faster and more reliably toward commercialization.

  6. Extractables, Leachables, And Risk: Ensuring Safety In Pharma Manufacturing 9/8/2025

    This session is designed for teams developing new products, optimizing processes, or preparing regulatory submissions, and will provide practical tools for a better approach to E&L management.

  7. Solving Fragmentation: Future-Proofing The Advanced Therapy Supply Chain 9/5/2025

    Whether you are preparing for your first clinical shipment or scaling for global distribution, this conversation provides strategies to streamline operations, improve reliability, and deliver better patient outcomes.

  8. New Group Wants 'Phase-Appropriate' Thinking To Retire 9/4/2025

    Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.

  9. Accelerate Innovation With Compliant Software Solutions 9/2/2025

    Accelerate your innovation with software solutions that are designed to streamline operations, reduce costs, and speed time-to-market while ensuring compliance and data integrity.

  10. Visual Inspection Of Advanced Therapy Medicinal Products 9/2/2025

    Discover how expert database systems for inspection defect management and control help cell and gene therapies meet the requirements of USP-790 to assure they are essentially free from particulate matter.