Regulatory Webinars

  1. Delivering Value In Clinical Trial Services By Managing Complexity, Timelines 3/4/2026

    Gain insights into managing global trial complexity, balancing accelerated timelines with compliance, using advanced technologies to improve efficiency, and leveraging partnerships to support seamless clinical operations.

  2. Plain Language Summaries A Necessity For Global Transparency 2/19/2026

    As regulatory authorities and industry stakeholders increasingly prioritize accessible communication, PLS are becoming not only a best practice but, in many regions, an emerging requirement.

  3. Measuring Treatment Tolerability In Oncology: Expert Panel Discussion 2/19/2026

    Learn how to synthesize individual symptomatic data into a comprehensive narrative of tolerability, ultimately enhancing the clinical value and regulatory positioning of your oncology assets.

  4. Charting The Path To First-In-Human: Strategic Readiness For Early Clinical Success 2/10/2026

    Gain a comprehensive, end-to-end perspective on the journey to first-in-human and understand how early decisions influence downstream success.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.