Bethesda North Marriott Hotel & Conference Center, Rockville, MD
Stop by Booth 5 in the Grand Foyer on Monday, October 27th and Tuesday, October 28th from 8 am to 6 pm and Wednesday, October 29th from 7:45 am to 2 pm.
Strengthen Your Compendial Strategy with USP
Visit our booth to discover how proactive engagement with USP can enhance your regulatory strategy and support global market success. Learn when and why to collaborate on standards development, how involvement in the process can reduce compliance risks by aligning your current regulatory requirements to future compendial requirements. Quality medicines benefit everyone: your organization gains competitive advantage while patients receive safe and effective treatments.
Don’t miss this opportunity to connect with USP experts and take a strategic step toward shaping the future of quality standards. Stop by and speak with USP experts— your future submissions will be strengthened from this proactive approach.
View the full agenda: https://grxbiosims.org/agenda/
USP participation
Monday, October 27 from 1:15 p.m. – 2:30 p.m.
The future of quality and maintaining a reliable supply chain
Tools and processes to assure the supply of high-quality, safe, and effective drugs are evolving. This session will explore various possible solutions that could improve both the quality and supply of generic and biosimilar medicines, including Quality Management Maturity (QMM), processes and policies related to inspections and surveillance, guidances, and marketplace dynamics.
- Djamila Harouaka, PhD
Senior Scientific Advisor, Office of Quality Surveillance (OQS), OPQ, CDER, FDA - Mayank Nagar, M.S., MBA
Vice President & Head of Technical Services and Product Launch Management, Dr. Reddy’s Laboratories Inc. - Jude Nwokike, PhD, MSc, MPH
Vice President, Supply Chain Resilience, USP - Vickram Srivastava, MBA
Head of Supply Chain – North America, Sun Pharma
Moderator: David Cragin, PhD, DABT
Senior Director, Occ & Env Hlth Sciences, Environment, Health, Safety and Sustainability, Teva Pharmaceuticals
Tuesday, October 28, 2025 from 1:30 p.m. – 2:45 p.m.
Managing Emerging Quality Threats and Challenges: HFAs, PFAS, Extractables/Leachables, FD&C Red No. 3, and Petroleum-Based Food Dyes
Many ingredients, components, and byproducts of drugs and processes related to drug manufacturing are being more heavily scrutinized for their effect on patients and the environment. This session will examine how manufacturers, regulators, and patients can work together to balance evolving safety and environmental considerations with the need to maintain timely access to medicines. Topics will include recent developments related to HFAs, PFAS, extractables and leachables, FD&C Red No. 3, and petroleum-based food dyes.
- Prabhakar Reddy, PhD, Senior Director, Pharmaceutical Science, Science-General Chapters & Complex Generics, USP
- David Schoneker, M.S., IPEC – Americas
- Kalpana Vanam, M.Sc., Senior Vice President, Regulatory Affairs, Lupin Pharmaceuticals
- Susan Zuk, MS, Branch Chief, OPQ, CDER, FDA
Moderator: Martin Ehlert, PhD, Vice President, Global API Technical, Apotex Inc.
Wednesday, October 29 from 9:00 a.m. – 9:30 a.m.
USP Fireside Chat
Moderator: John Murphy III President & CEO, AAM