Regulatory Webinars

  1. Blueprint For Efficient Clinical Trial Disclosure 4/21/2025

    Explore a comprehensive framework that helps organizations continuously assess and improve their clinical trial disclosure processes.

  2. Accelerating Clinical Data Review With Traceable Workflows 4/17/2025

    Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

  3. Unlocking Continued Revenue And Growth From Established Products 4/14/2025

    Gain insights into how pharmaceutical companies successfully handle post-approval regulatory upkeep for established products, focusing on reducing operational costs and expanding global market access.

  4. Inspection Readiness For Decentralized Trials 3/31/2025

    Decentralized Clinical Trials (DCTs) enhance research inclusivity by minimizing logistical barriers such as travel, scheduling conflicts, and costs, making participation more accessible.

  5. What Should You Ask The FDA About AI 1/27/2025

    Understanding what some of the common questions the FDA gets about AI may help you as you plan to interact with the agency.

  6. What Is 'Fit For Use' In AI Models? 1/27/2025

    The data that you use to train AI models has to be “fit for use” according to the FDA. Tala Fakhouri explains what metrics the FDA uses to make this determination.

  7. 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.

  8. 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.

  9. 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.

  10. 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.