Regulatory Webinars

  1. Drug Price Controls: What Are The Unintended Consequences To Innovation? 7/15/2025

    Review the ripple effects of drug price controls, including recent U.S. policy shifts like the IRA and President Trump’s Executive Order introducing International Reference Pricing.

  2. Navigating Regulatory Uncertainty: Diversity Action Plans 7/8/2025

    Sponsors planning Phase 3 and pivotal clinical trials are facing fresh uncertainty as the FDA’s Diversity Action Plan guidance continues to shift.

  3. Mitigating Risk With Ex-US Clinical Trials 7/8/2025

    Gain insight into why certain regions offer strategic advantages, from regulatory flexibility to faster enrollment, and how to effectively integrate them into your development strategy.

  4. Planning Your IND: When And Why To Engage The FDA 7/2/2025

    This presentation explores how and when to initiate IND activities, highlighting that sponsors can strategically open an IND to access FDA guidance and enable U.S. clinical trials.

  5. FDA Shifts Reshape Drug Development 6/13/2025

    Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.

  6. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

    Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

  7. Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook 6/12/2025

    This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

  8. Mastering The Complexities Of Gene Therapy Document Writing 5/20/2025

    Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.

  9. 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.

  10. 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.