Regulatory Webinars

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

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    The FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.

  7. All You Need To Know About 505(b)(2), But Were Afraid To Ask 7/18/2025

    Join us to explore the 505(b)(2) pathway. Learn how to bring improved drugs to market faster, reduce costs, and add value with this streamlined regulatory approach.

  8. Regulatory Advantages Of Clinical Trials In Canada Versus Australia 7/16/2025

    An expert answers your question about the regulatory advantages of conducting your clinical study in Canada versus Australia. Watch now to learn more.

  9. 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.

  10. Controlling Comment Chaos: A Medical Writing Leader's Story 7/14/2025

    Discover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.