Attached is the presentation.
Allison Radwick Ph.D.
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 03-21-2025 07:23
From: Allison Radwick
Subject: March 10 OSD: FDA's Draft Guidance on the Use of AI in Regulatory Decision-Making for Drug and Biological Products
Thank you to Stephanie Pasas-Farmer @Robert Dodge for the leading the open scientific discussion about FDA's Draft Guidance on the Use of AI in Regulatory Decision-Making for Drug and Biological Products!
Attached are the presentation, recording and answers to the questions.
Community Initiatives
• Bioanalytical Community - Artificial Intelligence/Machine Learning/Robotics sub-group
Contact Stephanie Pasas-Farmer, [email protected]
• Regulatory Sciences Community - Artificial Intelligence/Machine Learning Regulatory Sciences subteam
Contact Chair Amit Tiwari, [email protected] or
Vice Chair Allison Radwick, [email protected]
Goals:
1. Regulatory Focus – Stay updated on AI/ML regulations, assess impact, and ensure compliance.
2. Expertise & Guidance – Serve as a knowledge hub, supporting other communities on regulatory challenges.
3. Coordination – Align cross-communities activities to maintain compliance and best practices.
Connect with us! Is your community discussing AI/ML? Let's collaborate on programming for PharmSci 360, NBC, Summer Scientific Forum, webinars, discussions, and publications.
2025 PharmSci 360 Proposal Submission Deadline April 8, 5 PM ET
Rapid Fire Submission Deadline June 13, 5 PM ET
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 03-04-2025 11:40
From: Allison Radwick
Subject: March 10 OSD: FDA's Draft Guidance on the Use of AI in Regulatory Decision-Making for Drug and Biological Products
Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTP), Bioanalytical and Regulatory Science Communities on March 10, 2023, 12 pm – 1 pm EDT on the following topic:
FDA's Draft Guidance on the Use of AI in Regulatory Decision-Making for Drug and Biological Products
- Discuss key provisions of the FDA's draft guidance on AI in regulatory decision-making for pharmaceutical products and identify potential implementation challenges.
- Learn the perspectives from AAPS community members regarding the practical applications and limitations of AI in regulatory decision-making
- Share Community AI initiatives
Discussion Leaders
- Stephanie Pasas-Farmer, President and Founder at BioData Solutions Consulting and Software
- Robert Dodge, Bioanalytical and Immunogenicity Consultant
Discussion Organizers:
Stephanie Pasas-Farmer (President and Founder at BioData Solutions Consulting and Software), and Allison Radwick (US Pharmacopeia)
Please join the meeting from your computer, tablet or smartphone.
https://meet.goto.com/505947717
You can also dial in using your phone.
Access Code: 505-947-717
United States: +1 (646) 749-3122
Join from a video-conferencing room or system.
Meeting ID: 505-947-717
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Or dial directly: [email protected] or 67.217.95.2##505947717
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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