Where Science Meets Technology by Appsilon is a series of interviews and discussions focused on how technology can accelerate data science processes, particularly within life sciences and biopharmaceutical companies.
Each episode will explore various aspects of innovation and its potential to address challenges where traditional methods may fall short. We will feature internal experts from our delivery teams, along with clients and partners as guest speakers, providing valuable insights into the intersection of science and technology.
The podcast is brought to you by Appsilon.
Appsilon empowers Fortune 500 companies to leverage open-source technology for faster, data-driven decision-making in regulated environments
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Where Science Meets Technology by Appsilon is a series of interviews and discussions focused on how technology can accelerate data science processes, particularly within life sciences and biopharmaceutical companies.
Each episode will explore various aspects of innovation and its potential to address challenges where traditional methods may fall short. We will feature internal experts from our delivery teams, along with clients and partners as guest speakers, providing valuable insights into the intersection of science and technology.
The podcast is brought to you by Appsilon.
Appsilon empowers Fortune 500 companies to leverage open-source technology for faster, data-driven decision-making in regulated environments
#003 The Future of GxP Compliance in Pharma: R-based Submissions
🤖🧬 Where Technology Meets Science
34 minutes
8 months ago
#003 The Future of GxP Compliance in Pharma: R-based Submissions
#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/ __________________________________________ 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/
🤖🧬 Where Technology Meets Science
Where Science Meets Technology by Appsilon is a series of interviews and discussions focused on how technology can accelerate data science processes, particularly within life sciences and biopharmaceutical companies.
Each episode will explore various aspects of innovation and its potential to address challenges where traditional methods may fall short. We will feature internal experts from our delivery teams, along with clients and partners as guest speakers, providing valuable insights into the intersection of science and technology.
The podcast is brought to you by Appsilon.
Appsilon empowers Fortune 500 companies to leverage open-source technology for faster, data-driven decision-making in regulated environments
