Regulatory Webinars

  1. Anticipating And Adapting At Every Step Of Development 10/18/2024

    Review how Parexel's Oncology Site Alliance Network can support the accelerated timelines and flexibility required in early phase oncology studies.

  2. Oncology Clinical Trials Key Considerations: Planning For Success 10/18/2024

    Chief Scientific Officer Gabriel Kremmidiotis and CEO Yvonne Lungershausen from Avance Clinical delve into key strategies for conducting successful early-phase oncology trials for biotechs.

  3. From Crisis To Confidence: Ensuring Smooth Regulatory Submissions 10/8/2024

    Explore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.

  4. FDA's Vision On PRO Collection For RWE 9/24/2024

    In this presentation, a distinguished panel of experts illuminates the crucial role of patient-reported outcomes (PROs) in shaping regulatory decisions and drug development strategies, particularly in light of FDA expectations.

  5. The Diversity Mandate: Effective Strategies in Clinical Trials 9/5/2024

    The June 2024 release of the FDA’s guidance related to diversity in clinical trials gives more direction to the industry on this ongoing concern and details what trials need Diversity Action Plans (DAPs), what should be included, and how to submit them. Will this be the turning point that shifts the conversation surrounding diversity from marketing rhetoric to actual implementations?

  6. TMF SUMMER SHORTS: House Of The Inspector 8/29/2024

    Discover key steps you can take to not just survive an inspection, but take the TMF Throne.

  7. Unlock The Secrets Of Managing CTR In A Complex Development Landscape 8/29/2024

    Lost in the CTR maze? Watch this webinar to get your burning questions answered by industry experts. Ask about vendor coordination, CTIS integration, and EU strategies.

  8. Risk-Based Quality Review: Inside Out 8/29/2024

    Walk through how to manage and resolve the often conflicting internal and external directives to find the right path for you.

  9. Overcoming The Challenges Of Manufacturing And Clinical Trials 8/20/2024

    <p>Learn how CROs and CDMOs work in tandem to successfully address operational and regulatory challenges for pharmaceutical and biotech companies, and how this can determine study success or failure.</p>

  10. CMC Roadmap: Considerations For Small Molecules, Recombinant Proteins 8/16/2024

    This presentation guides viewers through essential questions and real-world scenarios, helping to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.