Regulations & Compliance STREAM

  1. 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.

  2. How ICH Oversight And AI Are Shaping The Future Of Clinical Trials 10/9/2025

    Explore how the new ICH E6 (R3) revisions are reshaping clinical trial oversight and examine how AI-driven tools like the Clinical Decision Suite can help sponsors enhance trial efficiency.

  3. TrialScope Intelligence 7/16/2024

    This easy-to-use platform reduces the risk of clinical trial disclosure noncompliance by tracking global disclosure regulations for you. Browse comprehensive regulatory authority and trial registry requirements.

  4. 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.

  5. Navigating The Unique Attributes Of Psychedelic Drug Development 1/22/2024

    Join our panel of experts for an in-depth review of the FDA's guidance on psychedelic drug development, exploring necessary methodological adaptations for safety, pharmacology, and efficacy.

  6. 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.

  7. US And EU Regulatory Expectations For Combination Products 6/11/2024

    Explore the regulatory nuances in the US and EU for combination products in this on-demand webinar. Key topics include differing regulatory requirements, the influence of new guidelines, and more.

  8. Evaluating Abuse Potential Of CNS-Active Drugs For EU And US Submissions 1/30/2023

    Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.

  9. Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence 3/15/2024

    Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.

  10. 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.