Regulatory Webinars

  1. Human Abuse Potential: Selecting A Positive Control 5/8/2026

    Choosing an effective positive control in HAP studies is critical but not always straightforward. Learn how to justify comparator and dose selection.

  2. Human Abuse Potential: CSS Interactions 5/8/2026

    Learn how, by embedding FDA engagement into the development process, sponsors can strengthen their abuse potential assessment and support smoother regulatory review.

  3. Pharmacy Considerations For Early Phase Trials 5/8/2026

    This presentation explores practical pharmacy considerations in early-phase clinical trials, offering real-world insights from experienced clinical research pharmacists.

  4. Definitive QT Evaluation - Clinical And Operational Considerations 5/8/2026

    QT strategy decisions affect timelines, cost, and regulatory outcomes. This presentation examines when early QT data can support a waiver, how guidance updates influence study design, and more.

  5. Human Abuse Potential: Subjective Ratings 5/5/2026

    Accurate subjective ratings are central to Human Abuse Potential studies. Learn how Visual Analog Scales are administered, what influences responses, and why data collection practices are essential.

  6. cGMP Compliant Pharmacy 5/1/2026

    See how experienced compounding support helps ensure study drugs are prepared accurately and consistently across administration routes, meeting cGMP requirements while supporting clinical protocols.

  7. Human Abuse Potential: Pharmacy Considerations 5/1/2026

    Master the complexities of controlled substance handling, over-encapsulation, and dosing strategies to ensure the data integrity and regulatory compliance of abuse potential assessments.

  8. Countdown To Compliance: Navigating New UK Requirements 4/15/2026

    Senior experts from the HRA, the ISRCTN Registry (BMC), and Quotient Sciences discuss the implications of New UK regulations for clinical trial registration for sponsors and how to maintain compliance.

  9. Stay Audit-Ready: Practical Compliance Insights For Research Sites 3/26/2026

    Gain an auditors insight into common compliance gaps and learn practical ways to strengthen audit readiness in sIRB studies.

  10. Comparator Selection And Supply: Best Practices For Clinical Success 3/25/2026

    Explore best practices for comparator selection and supply optimization in clinical trials, including sourcing strategies, risk mitigation, regulatory compliance, and real-world cost-saving case studies.