Regulatory Webinars

  1. Engage Early With The FDA On AI … Or Expect Problems 1/29/2026

    You've heard it before; sponsors must engage FDA early when using AI in clinical development. Hilary Marston warns that late engagement can cause irreparable damage to your regulatory strategy.

  2. CRL Transparency Comes With Real Trade-Secret Risks 1/29/2026

    Sure, increased transparency around Complete Response Letters sounds good, but Elizabeth Jungman warns that FDA’s new disclosure approach may expose sponsors’ confidential and commercially sensitive information.

  3. Can The FDA Easily Replace The Experience It Has Lost? 1/29/2026

    Elizabeth Jungman describes how early retirement programs and workforce reductions led to the loss of highly experienced FDA leaders, creating gaps in institutional knowledge that affect complex regulatory decisions.

  4. We Can't Really Interpret R3 In A Vacuum 1/29/2026

    Having problems interpreting ICH guidelines or deciding what to do next? Sophia McLeod offers some advice and resources, and then she also explains why she thinks it’s good that we’re living in this “show-your-work” kind of era.

  5. FDA Talent Loss Is Real — And It's Not Evenly Distributed 1/29/2026

    Hilary Marston discusses how staffing losses at FDA are uneven across divisions, with particularly heavy impact in innovative areas like AI and real-world evidence.

  6. Policy by Press Release Is Now a Real Problem 1/29/2026

    Sophia McLeod, advocacy advisor, at ACRO, explains what ACRO members are concerned about regarding the FDA staffing losses. She also talks about the effects of "policy by press release" rather than traditional notice-and-comment periods.

  7. Fast-Track Innovation, Address CMC Challenges In Expedited Pathways 1/26/2026

    Learn to overcome solubility challenges and utilize flexible development strategies to transition innovative treatments from early-phase trials to commercialization while ensuring patient safety.

  8. 3 FDA Approvals In 2025 That Shift The Landscape For 2026 1/20/2026

    In this presentation, Precision’s Chief Medical Officer and former FDA Director, Division of Oncology 2, Harpreet Singh, MD breaks down 3 FDA approvals from last year that are impacting 2026.

  9. The FDA Year In Review — And What Comes Next 1/14/2026

    The FDA didn’t sit still in 2025, and neither can you. Our industry insider panelists, Sophia McLeod, Elizabeth Jungman, and Hilary Marston, M.D., M.P.H. cut through the noise to explain which regulatory shifts, guidance updates, and inspection trends really matter for clinical trials in 2026 — and what you should do about them.

  10. Should Sponsors Provide Source Document Templates? 12/9/2025

    Here, we debate sponsor-provided source document templates, weighing regulatory guidance, compliance risks, and operational impacts for smarter clinical trial documentation decisions.