USP & DIA have long worked together to expand dialogue on medicine quality and regulatory excellence. As the regulatory landscape continues to evolve, collaboration among regulators, manufacturers, patients, and others is more essential than ever.
Stop by Booth 1339 to connect and learn more about USP, including an opportunity to demo USP’s Medicine Supply Map — discover how supply chain visibility can support your next supply decision.
USP participation
Monday June 16
FDA Appreciation Event
- Monday June 16, 5:30pm - 6:00pm EDT
- This event is complimentary and registration is not required.
WHO: Town Hall
Driving Innovation and Access - Global Collaboration in Medical Product Regulation
- Monday June 16, 3:45 - 4:45 EDT
- Location: 150AB
- Speakers:
- Hiiti Sillo, World Health Organization (WHO)
- Marion Laumonier, World Health Organization (WHO)
- Jude Nwokike, United States Pharmacopeia (USP)
- Mercedes Perez Gonzalez, World Health Organization (WHO)
- Maria Luis Pombo, Pan American Health Organization (PAHO)
Tuesday June 17
Roundtable Discussion
Building a Regulatory Landscape to Support CMC Innovation
Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Building a Regulatory Landscape to Support CMC Innovation (Monday, June 16 | 2:15pm - 3:15pm EDT). Space is limited.
- Tuesday June 17, 12:00pm - 1:00pm EDT
- Location: Exhibit Hall / Zone B
- Learning Objective: Identify ways to apply concepts and techniques from the session.
- Chair: Allison Radwick, PhD, RPh
Roundtable Discussion
International Regulatory Harmonization for Development of Medicines:
A Look at How far We’ve Come and Where We Go From Here Join the Regulatory Affairs
Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.
- Tuesday June 17, 2:55pm - 3:55pm EDT
- Location: Exhibit Hall / Zone A
- Learning Objective: Identify ways to apply concepts and techniques from the session.
- Chair: Chaitanya Koduri, DDS, MHS
Wednesday June 18
Content Hub
Bridging Global Gaps in Biosimilar Development: A Multi-Stakeholder Analysis of Regulatory Convergence and Quality Assurance
Explore National Regulatory Authorities’ expectations for quality data packages for biosimilars in the context of rapidly evolving regulatory science, including advanced analytical tools and the opportunity to reduce clinical data requirements.
- Wednesday June 18, 12:20pm – 2:50pm EDT
- Location: L Street Bridge
- Learning Objectives: Examine challenges identified by National Regulatory Authorities regarding review of quality data packages for biological products; Identify trends in regulatory expectations for analytical vs. clinical data and use of advanced analytical tools in biosimilar development; Understand opportunities and challenges in the use of public standards to meet regulatory expectations for biosimilars.
- Chair: Chaitanya Koduri, DDS, MHS
Roundtable Discussion
Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
Join the Advanced Therapies Community for a follow up round table discussion tied to session: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products (Tuesday, June 17 | 4:00pm - 5:00pm EDT). Space is limited.
- Wednesday June 18, from 2:55pm - 3:55pm EDT
- Location: Exhibit Hall / Zone A
- Learning Objective: Identify ways to apply concepts and techniques from the session.
- Chair: Brett Howard, JD, PhD
Session Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels
This session aims to explore the application of AI to drug labeling to enhance pharmacovigilance, reduce medication errors, and improve patient safety. Presenters will discuss the complexities and share real examples from both end-user and technology perspectives.
- Wednesday June 18, 4:00pm - 5:00pm EDT
- Location: 207A Session Chair(s) Daniele Sartori, MPharm, Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre
- Learning Objectives: Discuss opportunities to apply artificial intelligence (AI) to drug labeling to enhance labeling review, surveillance activities, and medication error reduction; Identify the complexities and barriers to applying AI techniques to modernize labeling-related activities.
- Speakers:
- Brett Howard, JD, PhD, Regulatory Perspective, USP, Senior Director, US Regulatory Policy
- Fatima Sabar, MSc, From Text to Intelligence: Architecting AI Systems for Drug Labeling and Pharmacovigilance, Bluenote AI, CEO and Founder
- Daniele Sartori, MPharm, AI in Drug Labelling: Toward Harmonized, Globally Aligned Product Information, Uppsala Monitoring Centre, Senior Pharmacovigilance Scientist
- Suranjan De, MBA, MS. Computerized Labeling Assessment Using AI, FDA, Deputy Director, Regulatory Science, OSE, CDER
Posters
Supply Chain Under Stress: A Data-Driven Analysis of Vulnerable Medicines
Bridging Global Gaps in Biosimilar Development: A Multi-Stakeholder Analysis of Regulatory
Convergence and Quality Assurance
- Wednesday June 18, 11:30pm – 1:30pm EDT
- Location: Exhibit Hall
View the full agenda: https://www.diaglobal.org/en/flagship/dia-2025/program/schedule/agenda