PDA - Parenteral Drug Association’s Post

Exciting times ahead in the life sciences industry as the FDA leads the charge in integrating AI and ML to revolutionise drug development. Discover how these technologies are speeding up research, optimising clinical trials, and enhancing drug safety. Link for the full article: https://lnkd.in/d7EUGsfr  Integrity can help you navigate this exciting frontier, ensuring that innovations not only meet clinical needs but are also aligned with ethical standards and regulatory compliance. #FDA #compliance #Integrity #consulting #AI

How can AI address the long development timeframes in biotech? AI and advanced tools offer partial solutions to the long timelines in biotech, but distribution remains a challenge due to regulatory limitations. There's a clear need for more freedom in drug advertising and distribution, given the ongoing barriers imposed by regulations, particularly for vital medical supplies.

Our members from across all 11 Phorums, came together to provide a response to the FDA discussion paper examining AI in pharmaceutical manufacturing. Responding to the 8 questions posed, our experts came together to provide a global view on the current state of AI in biopharmaceuticals. The team was led by our in house regulatory expert Isabelle LEQUEUX and the paper can be downloaded for free at the link below 👇 A great piece of collaborative work showing the power of BioPhorum #collaboration #connectivity #articifialintelligence #biopharmaceuticals #regulatory

BioPhorum members – both technical and regulatory subject matter experts – were brought together by the Regulatory Governance and External Partnerships team (REGx) to provide the FDA with their views on the current state of implementation of AI in industry. You can download the PDF for FREE here 👉🏻 https://okt.to/ikfPIB #biophorum #regulatory #collaboration

What EMA wants the MAH to do for implementing AI/ML automation Solutions ? - MAH holds the responsibility to validate and document the model performance and includes its operations in pharmacovigilance system, to mitigate risks related to algorithms and models used. #pharmacovigilance #artificialintelligence #machinelearningalgorithms #drugdevelopment PS: Based on the recent paper released by EMA.

Generative AI is already having an impact on various industries. Our Global Head of Healthcare and Life Sciences, V. "Bala" Balasubramanian, PhD, MBA, is presenting in an information session at the upcoming DIA Regulatory Submissions, Information, and Document Management Forum. The session will focus on real life examples of AI and Large Language Model applications in regulatory functions. Learn more about the DIA conference here: https://bit.ly/3RHbcS3 #Healthcare #RegulatoryCompliance #CurrentlyOrion #DigitalTransformation #Pharma #DIA

Did you miss our webinar on FDA’s regulation of AI-driven technologies as it relates to product development and manufacturing? Catch a recording of our insightful session hosted by AGG Food & Drug attorneys Alan Minsk and Laura Dona to learn about FDA’s statements on AI and how to maximize the AI opportunity, while minimizing regulatory risks. https://lnkd.in/eTAZ2Ttm

If interested, we made a recording of our webinar on FDA and AI. See below

By automating validation tasks, optimizing test plans, and ensuring meticulous traceability, valkit.ai empowers companies to achieve faster, more efficient compliance with modern quality standards. 🚀💡 #AI #SoftwareValidation #Pharma #MedicalDevices #RegulatoryCompliance