The United States Pharmacopeial (USP) held a virtual Prescription/Non-prescription Stakeholder Forum on Monday, April 11, 2022, and April 12, 2022, from 8:00 a.m. to 12:00 p.m.
This Forum presented an opportunity for stakeholders– industry and regulatory leaders and USP– to engage and exchange information and perspectives. The goals were to shape the development of compendial issues related to prescription and non-prescription drug quality standards and improve USP standards.
The Forum also served as a venue for USP staff to inform USP Compendial stakeholders of USP’s Stakeholder Engagement Model and opportunities to support the development of new standards.
Topics covered:
- Mechanisms for Enhanced Stakeholder Engagement
- USP Updates
- Prioritization of Standards
- Requested Cases for Monograph Modernization
- USP Quality Commitment
- Errata Past, Present, and Future
- Introduction to New General Chapter <1220> Analytical Procedure Life Cycle - Dialog between FDA, USP, & Industry
POST-DAY ONE EVENT
Ask Me Anything Sessions
It was an opportunity for stakeholders to ask USP Subject Matter Experts questions related to the topics:
- Guidance on aspects of Method validation for Companies
- Nitrosamines – Knowledge Sharing
Also Featured:
An open dialogue with Ronald T. Piervincenzi, Ph.D., Chief Executive Officer, concerning industry submitted questions.
Who participated?
- Pharmaceutical manufacturers
- Contract research organizations
- Pharmaceutical regulators
- Suppliers and related service providers
For further information, please get in touch with Jacqueline D. Starkes.
Event Summary
Day One Presentations:
1. Evolving to Meet Today’s Challenges and Opportunities, Dr. Ronald T. Piervincenzi, Chief Executive Officer
2. Mechanisms for Enhanced Stakeholder Engagement; Jennifer Devine, SVP, Documentary Standards & Compendial Policy; Ed Gump, Vice President, Small Molecules; Naiffer E. Romero, Senior Scientific Affairs Manager | USP and Danita Broyles, Chair ǀ Stakeholder Engagement Planning Committee
3. USP Updates
a. Preview of the upcoming USP-NF/PF integrated platform; Trey White, Senior Director, Digital Platforms & Delivery | USP
b. Overview of the Public Commenting Open Forum; Jessica Simpson, Senior Manager, Executive Secretariat | USP
4. Prioritization of Standards
a. Prioritization Approaches within Small Molecules; Ed Gump, Vice President, Small Molecules | USP
b. Our Donations Journey; Christine Feaster, Vice President, Global Commercial Operations | USP
c. USP Processes for Prioritization and Development of Standards; Mark Wiggins, Compendial Consultant with Global Pharmacopeia Solutions; and Joe Albanese, Consultant with Albanese Consulting
Day Two Presentations:
1. A Case for Modernization – Human Factors and Organoleptic Tests; Jose Zayas, CEO | Zaycor Healthcare Corporation
2. USP Cases of Modernization – General Chapters; Antonio Hernandez
3. USP Quality Commitment; Alice M. Tira, Vice President, Global Quality Systems ǀ USP
4. Errata Past, Present, and Future; Sarah R. Gaskin, Senior Manager, Publications Production ǀ USP
5. Introduction to New General Chapter <1220> Analytical Procedure Life Cycle; Amanda Guiraldelli, Scientific Affairs Manager | USP