• #003 The Future of GxP Compliance in Pharma: R-based Submissions

  • Mar 13 2025
  • Length: 34 mins
  • Podcast

#003 The Future of GxP Compliance in Pharma: R-based Submissions

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  • Summary

  • #datascience #dataanalysis #GxP #PharmaTech #SoftwareValidation #FDARegulations #ClinicalTrials #LifeSciences #R #PharmaInnovation #TechInPharma
    GxP compliance is shaping the future of pharmaceutical software engineering, yet many companies still struggle with implementation. In this episode, Appsilon’s co-founder, Paweł Przytuła, unpacks GxP best practices, software validation, and how R-based submissions are gaining traction with regulatory bodies like the FDA. He also shares industry insights from Roche, Novo Nordisk, and GSK, explores emerging trends like AI in validation, and discusses how pharma companies can leverage open-source tools while ensuring compliance. Don’t miss this deep dive into the intersection of software and life sciences!
    In this episode, you will learn:
    What is GxP in software engineering and why it’s critical for regulatory approval in life sciences
    What GxP compliance means for pharma software
    How leading pharma companies approach R-based submissions
    What are the risks of ignoring GxP in software development
    How AI, statistical computing environments (SCEs), and open-source innovations are transforming software validation in pharma
    How to build a strong GxP-ready data science team

    Guest: Paweł Przytuła https://www.linkedin.com/in/pawelprzytula
    Your host: Nat Chrzanowska https://www.linkedin.com/in/nat-chrzanowska/
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    Mentioned resources:
    Paper on R-based Submissions to the FDA: https://pharmasug.org/proceedings/2024/SS/PharmaSUG-2024-SS-344.pdf
    Presentation on Novo Nordisk's Journey towards open source: https://phuse.s3.eu-central-1.amazonaws.com/Archive/2023/Connect/EU/Birmingham/PRE_TT12.pdf
    GSK's R Journey to Open Source: https://www.youtube.com/watch?v=xDrt6txplek&ab_channel=PositPBC
    Roche's End-to-End R Journey to Submission: https://www.youtube.com/watch?v=BlJNILSoZlM&ab_channel=PositPBC
    __________________________________________
    More about Appsilon:
    ► https://www.appsilon.com/
    Appsilon empowers pharmaceutical and life sciences companies to leverage open-source technology for faster, data-driven decision-making in regulated environments. Schedule a free consultation with our expert
    ► https://www.appsilon.com/contact-us
    __________________________________________
    For more insights about how technology helps scientists push the boundaries of data analysis and reporting check out our blog:
    ► http://appsilon.com/blog
    LinkedIn: https://www.linkedin.com/company/appsilon/
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