Regulatory Webinars

  1. 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.

  2. 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.

  3. Navigating The Digital Era And Beyond For Engaging Key Decision Makers In Specialty Pharmacy 1/17/2025

    Tune in as experts discuss how biopharma companies can effectively engage healthcare decision-makers in the evolving digital landscape.

  4. Uncovering The Root Cause Of Clinical Trial Troubles 12/10/2024

    Discover essential strategies to prevent clinical trials from reaching a crisis while gaining a deeper understanding of the importance of addressing systemic issues early.

  5. Implementing A Diversity Plan For Your Clinical Trial 12/5/2024

    Industry leaders dive into the FDA’s Diversity Action Plans and practical strategies for integrating diversity action plans into clinical trial operations in a presentation centered around enhancing trial diversity.

  6. Strategies For Research Institutions In An Evolving Era Of Oncology 11/11/2024

    As biomarker-directed therapies drive advancements in the oncology space, experts are reviewing cutting-edge trends and strategies that help institutions address ethical and regulatory challenges.

  7. The Benefits And Challenges Of Clinical Trial Standards And Automation 11/9/2024

    Jessica Jolly discusses some of the benefits and challenges associated with implementing standards and automation in clinical trials.

  8. How will the ICH M11 guideline impact future clinical trials? 11/9/2024

    Hassan Khalid of AstraZenca talks about how he sees the ICH M11 guideline impacting future clinical trials, specifically after a data lock.

  9. What does the data science industry have to say about the ICH M11 Guideline? 11/9/2024

    As the ICH M11 guideline nears approval, Hassan Khalid of AstraZenca and Jessica Jolly, a senior data and science executive, talk about how they feel about it and what they’ve been hearing from their peers in the data science industry.

  10. The Benefits Of The New ICH M11 Guideline 11/9/2024

    With 25 years of global data science experience, Jessica Jolly gives a quick overview of the ICH M11 guideline and talks about some specifics of its two pillars: standardization and automation.