Regulations & Compliance STREAM

  1. Navigating Early Phase CNS-Active Drug Development 2/14/2023

    Early development of CNS-active drugs requires in-depth clinical expertise. Altasciences’ Dr. Beatrice Setnik, Chief Scientific Officer, examines the strategies to ensure early comprehensive data collection to fulfill regulatory requirements and aid in evaluating the risk/benefit profile.

  2. 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.

  3. The FDA's View Of AI In Clinical Trials Is Limited 1/27/2025

    Tala Fakhouri explains that there could be so many more applications of AI in clinical development than what the FDA sees in regulatory submissions.

  4. Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence 3/15/2024

    Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.

  5. Ensuring Compliance In Gene Therapy Trials: IRB And IBC Views 9/23/2025

    Explore ethical and regulatory challenges in neurological gene therapy trials, with expert insights on IRB/IBC collaboration, consent protocols, and oversight for vulnerable populations.

  6. How ICH Oversight And AI Are Shaping The Future Of Clinical Trials 10/9/2025

    Explore how the new ICH E6 (R3) revisions are reshaping clinical trial oversight and examine how AI-driven tools like the Clinical Decision Suite can help sponsors enhance trial efficiency.

  7. Exploring The FDA's Draft Guidance On Psychedelic Drug Research 7/26/2023

    Discover the crucial insights and methodological adaptations needed to effectively assess the safety, pharmacology, and efficacy of innovative psychedelic compounds designed for specific medical applications.

  8. TrialScope Intelligence 7/16/2024

    This easy-to-use platform reduces the risk of clinical trial disclosure noncompliance by tracking global disclosure regulations for you. Browse comprehensive regulatory authority and trial registry requirements.

  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. The Benefits Of Conducting A Clinical Trial In Canada 9/19/2023

    Watch this video in which Altasciences’ regulatory experts share key insights on Health Canada’s Clinical Trial Application (CTA) regulatory submission process.