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About this Event (Hosted by CDER SBIA)

By hosting this workshop, the Association for Accessible Medicines (AAM), FDA, and United States Pharmacopeia (USP) aim to increase stakeholder awareness of, and participation in, the USP standards development process, ultimately contributing to product quality and regulatory predictability throughout the drug development, approval, and product lifecycle.

Public quality standards are universally recognized as essential tools that support the design, manufacture, testing, and regulation of drug substances and products. USP standards play a critical role in helping ensure the quality and safety of medicines marketed in the United States and worldwide.

This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs. Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate—via public comment—in the development of future standards.

Intended Audience

• Regulatory Science & Affairs Professionals: Professionals in regulatory science, regulatory affairs, quality assurance, and product development—across both brand-name and generic drug industries—who submit or support IND, NDA, BLA, ANDA, NADA, and ANADAs.
• Regulatory Decision-Makers: Government regulators—including application reviewers and policy makers—interested in gaining a deeper understanding of USP standards development processes and how these standards support regulatory decision-making and help protect public health.
• Brand-name and Generic Drug Industry Representatives: Quality managers, regulatory specialists, and compliance officers from brand-name and generic drug companies who ensure products are marketed in compliance with federal law, including GMPs and other regulatory requirements, and who need to understand compendial standards for drug development and approval.
• Consultants: Regulatory and quality consultants specializing in pharmaceutical compliance, standards implementation, and method validation, who work with clients to navigate USP standards for market authorization and post-market compliance.

Topics Covered

• FDA’s responsibility in USP standards development
• Value/role of USP monographs for FDA
• Understanding how the use of standards - and demonstrated compliance - factor into FDA’s regulatory activities
• Industry’s position in USP standards development
• Manufacturers’ part in the establishment of USP standards
• Overview of USP standards in regulatory framework
• Discussion of the USP revision process
• How to get involved in monograph development

Speakers

Industry Role in USP Standards Development
Scott Kuzner
Senior Director | Science and Regulatory Affairs
Association for Accessible Medicines

FDA’s Participation in USP-NF Revision Process- Challenges and Solutions
Pallavi Nithyanandan
Director | Compendial Operations and Standards Staff
Office of Pharmaceutical Quality
Center for Drug Evaluation | FDA

USP Standards: Value to Industry and Regulators
Matthew Vankoski
Director | Donations
United States Pharmacopeia (USP)

Panelist

Kristie Laurvick
Senior Regulatory Engagement Manager
U.S. Government and Regulatory Affairs | USP

Resources