Regulatory Webinars

  1. Single-Arm Studies For Use As A Registrational Study In Oncology 6/26/2023

    Listen in as industry experts discuss single-arm oncology registrational studies, success stories, and lessons learned.

  2. Strategies For Achieving Regulatory Milestones Faster 6/20/2023

    Explore how a vendor that offers integrated drug substance, drug product, and clinical testing activities under one organization facilitates improved communication and a more agile approach to development.

  3. Trial Protocol Design Do's And Don'ts 6/14/2023

    Designing a clinical trial protocol that exhibits the value of a new drug is central to bringing innovative treatments to market. Listen in as experts share tips for ensuring no missteps go unnoticed.

  4. The eTMF As A Regulatory Standard 6/1/2023

    Discover essential insights on maintaining a high-quality Trial Master File (TMF) in a discussion about ICH GCP Essential Documents and the different regulations that apply to the TMF.

  5. Leverage DHT Data As Patient-Centric Primary Endpoints 5/23/2023

    See how digital outcome measures of physical activity collected from ActiGraph technology as the primary endpoint in a pivotal cardiopulmonary trial were endorsed by the FDA, marking an important milestone. 

  6. Best Practices For Executing EDC Protocol Amendments 5/17/2023

    Bioforum’s Tanya du Plessis discusses the benefits of reducing EDC amendment cycle times by 70% compared to traditional EDCs.

  7. Keeping Pace With The Evolving Global Landscape In Vaccine Development 5/9/2023

    Hear from a panel of life science experts about the most recent developments and ground-breaking approaches shaping the field of vaccine development worldwide.

  8. Regulatory And Commercial Insights To Maximize Digital Health 4/27/2023

    Gain insight into opportunities that leverage regulatory pathways and factors that will ultimately determine the commercial success or failure of digital products currently in development.

  9. The Hidden Regulatory Risk In Biospecimen Sample Management 4/24/2023

    Sponsors, CROs, and sites should consider these regulations and researchers’ responsibilities when working to proactively plan for their next clinical trials involving biospecimens.

  10. Meet ICH E14 Requirements With This Phase I/TQT Cardiac Assessment 4/12/2023

    Fulfill ICH E14 requirements early, minimize risk, and potentially reduce costs throughout clinical trials by collaborating with Clario’s Phase 1 Center of Excellence.