Regulatory Webinars

  1. Balancing Science With Intellectual Property 5/16/2025

    Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.

  2. 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.

  3. Assessing Diversity In Early-Phase Clinical Trials In A Rapidly Changing Regulatory Environment 5/5/2025

    Learn more about structuring early-phase trials to address population variation and the contributing factors to safe drug administration, both of which are essential to a drug development plan.

  4. 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).

  5. Blueprint For Efficient Clinical Trial Disclosure 4/21/2025

    Explore a comprehensive framework that helps organizations continuously assess and improve their clinical trial disclosure processes.

  6. 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.

  7. Unlocking Continued Revenue And Growth From Established Products 4/14/2025

    Gain insights into how pharmaceutical companies successfully handle post-approval regulatory upkeep for established products, focusing on reducing operational costs and expanding global market access.

  8. Inspection Readiness For Decentralized Trials 3/31/2025

    Decentralized Clinical Trials (DCTs) enhance research inclusivity by minimizing logistical barriers such as travel, scheduling conflicts, and costs, making participation more accessible.

  9. 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.

  10. What Is 'Fit For Use' In AI Models? 1/27/2025

    The data that you use to train AI models has to be “fit for use” according to the FDA. Tala Fakhouri explains what metrics the FDA uses to make this determination.