Regulatory Insights

  1. Beyond The Checkpoint — Next-Gen Strategies In Immuno-Oncology 11/24/2025

    Gain a clearer view of the scientific, operational, and regulatory forces propelling the next wave of oncology innovation — and what they mean for sponsors advancing cutting-edge cancer therapies.

  2. ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations 11/21/2025

    Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.

  3. Your Neurological Gene Therapy Trial's Secret Weapon: Caregiver Support 11/20/2025

    When it comes to neurological gene therapy trials, sponsors must prepare for participants losing the capacity to consent by enlisting the support of caregivers and legally authorized representatives.

  4. Unlock Robust And Reliable Stability Data With The Right Partner 11/19/2025

    Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

  5. Empowering Patients And Tackling Orphan Drug Development Challenges 11/18/2025

    Successful rare disease trial design requires patient-centric approaches. Experts share how to embed the patient voice, optimize site readiness, and balance feasibility with essential regulatory rigor.

  6. EU GMP Annex 11: Compliance Strategy And Digital Solutions 11/18/2025

    Explore how EU GMP Annex 11 revisions could reshape global pharmaceutical compliance, as well as strategies for navigating implementation challenges and building future-ready validation programs.

  7. The Growing Complexity Of Conducting Oncology Trials 11/17/2025

    As diversity plans and multi-regional considerations become core to trial design, early-phase oncology programs must navigate a landscape that offers unprecedented opportunity.

  8. Dose Optimization: A Strategic Lever In Oncology Drug Development 11/17/2025

    Targeted therapies, immunotherapies, antibody–drug conjugates, and other biologics demand a patient-centered strategy that recognizes that higher doses do not always translate to better outcomes.

  9. New ICH GCP Changes Center The Patient 11/7/2025

    Learn how the updated ICH GCP E6(R3) guidelines are transforming clinical trials with a focus on patient centricity, digital innovation, and risk-based quality management.

  10. Clinical Trial Disclosure Fundamentals 11/7/2025

    Failing to comply with disclosure rules can leave sponsors open to fines and penalties. Here, we present the latest disclosure requirements, enforcement mechanisms, and tips on how best to stay compliant.