Regulatory Webinars

  1. 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.

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    The FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Strategies For QA Professionals In Life Sciences 7/14/2025

    Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

  8. 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.

  9. Mitigating Risk With Ex-U.S. 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.

  10. 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.