Time: 9:00 am–5:00 pm (Eastern Time)
The United States Pharmacopeial Convention (USP) will be hosting an Excipients Stakeholder Forum on Wednesday, November 13, 2019, at USP global headquarters in Rockville, Maryland, from 9:00 a.m. - 5:00 p.m. To expand the opportunity for stakeholder participation, USP offers a web-based option for those who wish to attend the meeting remotely. Registration is required for both The USP Excipients Stakeholder Forum has been created to enable an exchange of information and perspectives between USP and users of USP standards, with the ultimate goal of improving USP standards.
The Excipients Stakeholder Forum will provide an opportunity for manufacturers, distributors, users of excipients, and regulatory agencies to discuss topics in an open forum setting. USP hopes the forum will encourage excipients constituencies to work openly and directly with USP as well as collaborate with fellow stakeholders. Registration is free for both in-person and remote attendance; it is also required. For further information or to suggest additional stakeholder topics, please contact Jacqueline D. Starkes.
Objectives
- Extending opportunities for participation to a broad range of excipients stakeholders to ensure industry-wide input to USP
- Educating stakeholders on USP activities while helping USP staff understand excipients issues
- Providing information on emerging USP initiatives that might affect excipients stakeholders
Presentations
- 1. Updates from the Fall 2018 Excipients Stakeholder Forum, Chair, Lisa Parks
- 2. USP Excipient Initiatives: Together, How Can We Ensure the Quality of Medicines?, Danita Boyles and Stephen Andruski, USP
- 3a. Excipient Nomenclature Development - FDA Draft IID Guidance Comments, Hong Wang, USP
- 3b. Excipient Nomenclature - Priscilla Zawislak, Industry Perspective
- 3c. Excipients Nomenclature, Frank Switzer, FDA
- 4. Call for Candidates: Recruiting the Next Generation of Volunteers, Melissa Bellon, USP
- 5. USP NF Online Updates: Progress Towards a Digital Future, Rebecca Cambronero, USP
- 6. Novel Excipients - Update on Recent Survey Findings, Catherine Sheehan, USP
- 7a. General Chapter <1059> Excipient Performance Updates, Galina Holloway, USP
- 7b. Pending Monographs for Excipients, Amber Day, USP
- 7c. Public Input Lifecycle and Impact Program (PILIP) Update, Jessica Simpson, USP