Regulatory Webinars

  1. The New Era Of Project Optimus: Implications for Oncology Development Strategy 9/10/2025

    In this presentation, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples.

  2. Best Practices For Operationalizing Global, Early-Phase Oncology Trials 9/10/2025

    In this presentation, industry experts will share real-world lessons learned from managing global early-phase oncology trials.

  3. Navigating What's Next For Global Drug Development: What Sponsors Need To Know 9/10/2025

    Learn how new FDA initiatives and global regulatory changes can impact your strategy for 2025 and beyond.

  4. Exploring Ex-US Markets To Reduce Risk For Your Clinical Trials 9/10/2025

    How biotech and emerging pharma companies are increasingly leveraging regions such as APAC and Eastern Europe to accelerate trial start-up, secure high-quality data, and optimize costs.

  5. Prioritizing Safety In Clinical Trials 8/27/2025

    This presentation explores organizational culture and the values that are essential to delivering high-quality safety oversight.

  6. Navigating The Regulatory Complexities Of Targeted Medicines In Oncology 8/22/2025

    Explore the strategic considerations for successfully navigating the regulatory complexities of targeted medicines. Learn about the challenges in translational medicine and key clinical development considerations.

  7. Thinking Ahead: How Integrated Development Plans Improve Product Success 8/12/2025

    How can integrated development planning reduce development timelines and increase your chances of commercialization success? Industry experts reveal how this approach helps avoid common pitfalls.

  8. Understanding The Evolving Landscape Of Anti-Obesity Medication (AOMs) 8/12/2025

    Discover the evolving landscape of AOMs as a value and access expert shares the latest payer coverage trends, concerns, and strategies. Learn how payers are making critical coverage decisions.

  9. The 3 FDA Oncology Approvals That Will Have The Biggest Impact In 2025 7/25/2025

    The FDA wrapped up 2024 with 3 notable approvals. Harpreet Singh, MD and CMO, provides a recap.

  10. The FDA's New Guidance May Be Shaking Up Biotech 7/25/2025

    The FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.