Agenda Registration Pre-read material
The United States Pharmacopeial (USP) will be holding a virtual Prescription/Non-prescription Stakeholder Forum from Wednesday, November 18 through Thursday, November 19, 2020. Registration is free and advance registration is required.
This virtual Forum presents an opportunity for stakeholders– industry and regulatory leaders and USP– to engage and exchange information and perspectives. The goals are to shape the development of compendial issues related to prescription and non-prescription drugs quality standards and improve USP standards.
The Forum will also serve as a venue for USP staff to inform USP Compendial stakeholders of USP’s Standards Engagement Model, work in progress, and opportunities to support the development of new standards.
For further information or to suggest additional stakeholder topics, please contact Jacqueline D. Starkes.
Suggested topics:
- USP’s new Standards Engagement Model
- Updates to the Accelerated Revision Process
- Potential Alternate Bacterial Endotoxins Testing (BET) based on chemical analytical methods – Industry perspective
Who should participate?
- Pharmaceutical manufacturers
- Contract research organizations
- Pharmaceutical regulators
- Suppliers and related service providers
Pre-read material
- Introduction to USP’s Pending Monograph Process (PMP) Webinar
- Introduction to USP’s Pending Monograph Process, Presentation, Amber Day, USP
- Potential Alternate Bacterial Endotoxins Testing (BET) based on Chemical Analytical Methods – Opportunities for Industry, Prabhakar Gruddanti, USP
- Analytical Instrument Qualification in the USP-NF: Establishing Fitness for Purpose, Lucy Botros, USP
- General Chapter <7> Labeling, Misti Spann, USP
- General Chapter <1469> Nitrosamine Impurities, Edmond Biba, USP