Regulations & Compliance STREAM

  1. The Advantages Of Conducting Early Phase Trials In North America 10/24/2023

    In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.

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 Exploring The FDA's Draft Guidance On Psychedelic Drug Research 7/26/2023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

  3. 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.

  4. Accelerate Time To Target Endpoint In Cardiometabolic Studies Using Patient-Centered Technology Solutions 6/14/2022

    In this webinar, industry experts share their perspectives on how to address drug development challenges within cardiometabolic clinical studies and provide input on the impact of new regulatory guidance such as the DEPICT Act.

  5. 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.

  6. AI Meets Informed Consent: Opportunity, Risk, And What IRBs Need To See 5/14/2026

    Expert perspectives on IRB oversight, health literacy, and research ethics offer practical guidance to strengthen consent, protect participants, and align compliance with real-world research.

  7. Exploring The Principles Integral To Rare Disease Drug Development 6/12/2024

    This on-demand webinar offers valuable insights into successful rare disease drug development, including study design, regulatory engagement, and market access strategy.

  8. Plain Language Summaries Becoming A Mandate Worldwide 6/13/2024

    A growing number of countries are requiring clinical trial protocol and results disclosures to be written in plain language, influencing how these documents are authored.

  9. Managing A Continually Evolving Disclosure Landscape 2/20/2024

    Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.

  10. 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.