Featured Insights

  1. Vigilance Guidance Provides Greater Clarity On MDR Requirements 6/12/2024

    Explore how new vigilance guidance under MDR clarifies reporting obligations for high-risk medical devices, ensuring enhanced safety oversight and compliance amid stricter regulations.

  2. How Intuitive Decision Rules In Clinical Trials Can Support Regulatory Requirements 6/12/2024

    See how Bayesian decision rules in clinical trials can align with regulatory standards, offering intuitive and adaptive solutions amidst traditional challenges in frequentist frameworks.

  3. EMA's Concept Paper On Confirmatory Clinical Studies A Welcome Step For Industry 6/12/2024

    Explore the implications of the European Medicines Agency's Concept Paper, its potential impact on biosimilar developers, and the broader implications for the pharmaceutical industry.

  4. Navigating Promotional Materials Requirements In Europe 6/12/2024

    From navigating local laws to strategic planning, explore how companies can manage their promotional campaigns while adhering to strict regulatory guidelines.

  5. Opportunities And Risks As Biosimilars Come Of Age 6/12/2024

    As biosimilars mature, they promise expanded patient access and healthcare savings. Despite regulatory hurdles, collaboration and innovation will drive their future growth and impact.

  6. How AI Can Support The Trial Master File 6/12/2024

    As industries embrace AI's potential, its application in Trial Master File (TMF) processes shows promise for efficiency gains and improved quality control in clinical trials.

  7. Why Access Consortium Makes Sense For Industry And Regulators 5/22/2024

    The Access Consortium has significantly advanced regulatory convergence, creating synergies and sharing knowledge among its members. Here’s why it is beneficial for both industry and regulators alike.

  8. Realizing Business Benefit And Inspection Readiness With A Solid CAPA Framework 5/8/2024

    Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.

  9. Getting The CAPA Framework Right The First Time 5/8/2024

    CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.