Regulatory Webinars
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Unlocking The Promise of Digital Health Technologies In Clinical Trials
3/23/2026
Discover the scientific, regulatory, and operational hurdles slowing digital health in clinical trials — and how design, guidance, and validation improvements are moving adoption ahead.
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Transform Clinical Data Management Through A Unified Workspace
3/23/2026
Discover how unified clinical data infrastructure replaces spreadsheets with AI-driven oversight, delivering traceable decisions and regulatory-ready documentation that accelerates timelines.
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AI-Powered Custom Listing Generator
3/23/2026
Explore how natural language queries enable instant clinical listings while maintaining oversight, as well as what becomes possible when teams reduce manual effort without sacrificing control.
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Behind The Submissions: Regulatory Experts Share Their Experiences
3/17/2026
From gap analyses and tailored strategies to leading pre-IND and pre-CTA meetings, we ensure you’re fully prepared — with cross-functional alignment, rehearsals, and submission-ready documentation.
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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.
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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.
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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.
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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.
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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.
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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.