Regulations & Compliance STREAM

  1. 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.

  2. The Many Facets Of Early Phase Evaluation Of Psychedelics In Psychiatry 2/3/2023

    Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.

  3. An Overview Of Health Canada's CTA Process 10/24/2023

    Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.

  4. Is EU CTR Driving Tighter Clinical & Regulatory Integration? 3/31/2022

    The new Clinical Trials Regulation (EU) 536/2014 has raised critical questions about business process and data interactions between Clinical and Regulatory in biopharmaceutical companies. Did you know that as of 6 March 2022, there were more than 200 draft applications in CTIS?

  5. Think Canada: The Team Behind Your Clinical Trials 9/29/2023

    Altasciences has a bioanalytical and clinical facility in Canada. In this video, we unveil the advantages of conducting trials in Canada while introducing some of the faces that work behind the scenes on your studies.

  6. Ensure Regulatory Success With Support From Your IRT Partner 10/3/2025

    In this presentation, you’ll get recommendations to help you stay inspection-ready and learn about the importance of clear roles, audit trails, data integrity, and training.

  7. 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.

  8. 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.

  9. AI In Action: Transforming Clinical Trials 1/23/2025

    Tala Fakhouri, associate director for data science and ai policy at the FDA, along with industry consultant Elena “Ella” Sinclair of FlexPoint Bio, talk about common applications of AI in clinical development and the new AI-focused regulatory Guidance from the FDA.

  10. The Journey From File To Trial: Automating Regulatory To TMF 2/9/2021

    In this webinar, we explore the value of automation between the Trial Master File (TMF) and Regulatory solutions.  This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data entry.