FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing: An Opportunity for Stakeholder Engagement
A Virtual Event: Tuesday – Wednesday, September 26-27, 2023
Key Speakers from FDA, Academia, and Industry
Workshop Description: This FDA/PQRI Workshop brought together leaders from regulatory agencies, industry, and academia to discuss critical topics related to the use of artificial intelligence (AI) in pharmaceutical manufacturing.
The National Academies of Sciences, Engineering, and Medicine (NASEM) noted that FDA is likely to see substantial innovations in pharmaceutical manufacturing which may impact process measurement, modeling, and control. AI technologies represent an area of rapid technology growth for designing, monitoring, and controlling manufacturing processes. Such AI technologies may challenge traditional approaches to regulating pharmaceutical manufacturing.
This workshop aimed to facilitate interaction among AI stakeholders on critical areas for development, implementation, and regulatory consideration including uses in process development and control, operation of Pharmaceutical Quality Systems, lifecycle approaches, and Current Good Manufacturing Practice.
The FDA published a discussion paper on this topic in the Federal Register. Visit the FDA FRAME (CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative) website for updates on this topic.
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” on the use of artificial intelligence (AI) across the product life cycle of “medical products,” defined to include biological products, drugs, devices, and combination products. The Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) jointly issued this paper.
Workshop Materials
The final program is available to download here.
Speaker Bios for Day 1 (September 26, 2023)
Speaker Bios for Day 2 (September 27, 2023)
Presentations
Click here to access the presentations.
Questions?
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5607 or PQRISecretariat@pqri.org.