Regulations & Compliance STREAM

  1. An Overview Of Health Canada's CTA Process 10/24/2023

    Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.

  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. Accelerating Clinical Data Review With Traceable Workflows 4/17/2025

    Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

  4. 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.

  5. 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.

  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. 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.

  8. Overcoming The Challenges Of Manufacturing And Clinical Trials 8/20/2024

    <p>Learn how CROs and CDMOs work in tandem to successfully address operational and regulatory challenges for pharmaceutical and biotech companies, and how this can determine study success or failure.</p>

  9. Achieving Regulatory Compliance With A Unified Immunogenicity Strategy 5/10/2025

    This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.

  10. 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.