Podcasts

  1. Tackling Performance Requirements In The World Of IVDR 4/5/2023

    In this podcast episode focused on navigating the heightened performance requirements of the IVDR, Keely So provides valuable insights and strategies to effectively tackle these regulatory challenges.

  2. Gaining Efficiency With Statistical Solutions In A GxP Setting 3/15/2023

    Take a moment to investigate the necessity and methods for implementing fully automated solutions and processes to mitigate repetition and enhance overall operational efficiency.

  3. Managing The Medical Device Pre-Submission Process With The FDA 1/17/2023

    Mohammad Asad offers valuable insights and strategies gleaned from his expertise, illuminating effective approaches to navigate this critical regulatory pathway.

  4. Digitalization As A Tool In The Outsourcing Journey 1/9/2023

    Understand why the integration of digitalization, particularly automation and AI, is instrumental in optimizing processes and strengthening the effectiveness of these outsourcing relationships.

  5. Improve Efficiency And Mitigate Risk Through Strategic Development 12/5/2022

    Explore the concept of strategic product development as a pivotal component of an integrated strategy aimed at delivering new drugs to patients in need.

  6. Bayesian And ICHQ2 And Q14 10/6/2022

    Here, Bruno Boulanger, Ph.D., investigates how Bayesian statistics enables the extrapolation of observations made during analytical procedure validation to predict uncertainty surrounding future results, thereby bridging existing gaps in the guidelines.

  7. How Bayesian Thinking Addresses Complex Issues With Clinical Studies 9/8/2022

    In this podcast episode exploring how Bayesian thinking addresses complex issues in clinical studies, Brad Carlin offers invaluable insights drawn from his extensive expertise in statistical research and methodological approaches.

  8. How The MDR Has Changed The Roles And Responsibilities Of 'Economic Operators' 8/8/2022

    Explore the evolving roles and responsibilities of "economic operators" under the MDR as Clare Huntington offers insights from her experience navigating the regulatory landscape of medical devices.

  9. Opportunities In Pharmaceutical Outsourcing: Portfolio Maintenance 7/6/2022

    The emerging frontier in outsourcing involves managing established products, offering revenue sustainability, cost-efficiency, and compliance assurance.

  10. Solving The Innovation Dilemma With Integrated Product Development 6/1/2022

    Insights from a recent survey of senior pharmaceutical and biotech executives reveal the rising significance of IPD programs in efficiently launching new drugs to market.