Regulations & Compliance STREAM

  1. 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.

  2. Managing A Continually Evolving Disclosure Landscape 2/20/2024

    Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.

  3. The Big Picture: Impact Of EU Disclosure On Small & Mid-Size Sponsors 5/6/2019

    With the new EU clinical trial registry portal expected to launch next year, it’s imperative that sponsors – particularly small and mid-size organizations – understand the complexities of EU disclosure. Thomas Wicks, an expert in clinical trial disclosure, and Karen Rutkowski, an expert in medical writing, share actionable insights on compliance.

  4. Beyond First Impressions: CTIS Lessons Learned In First 3 Months 5/19/2022

    Now that the EU’s Clinical Trials Information System (CTIS) is up and running, disclosure and transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KgaA discuss the ins and outs of registering clinical trials and submitting study information to the portal.

  5. Stay Audit-Ready: Practical Compliance Insights For Research Sites 3/26/2026

    Gain an auditors insight into common compliance gaps and learn practical ways to strengthen audit readiness in sIRB studies.

  6. Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy 5/2/2025

    In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).

  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. PLS Perspectives: Sponsor, Author & Regulatory Viewpoints 2/24/2020

    In this informative webinar, Jazz Pharmaceuticals will provide tips on launching a PLS program. A medical writer from ClaritiDox will give an overview of PLS best practices. And TrialScope’s chief strategy officer will share – and analyze – results from TrialScope’s recent PLS survey.

  9. Quality Checks Vs. Quality Review 8/22/2023

    Watch this presentation where speakers share how teams can improve inspection readiness and reduce potential regulatory risks that could negatively impact operational activities.

  10. Taking A Risk-Based Approach To An Inspection-Ready Audit Trail 2/10/2021

    Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspection.