US Pharmacopeial Convention
12601 Twinbrook
Parkway Rockville, MD 20852
Tuesday, December 10, 2024 | 9:00 a.m. – 1:00 p.m. (US Eastern Time)
Sign up for the Free Event Agenda
Overview:
Join industry, compendial, regulatory and scientific experts at the USP / IQ Consortium summit on December 10, 2024.
Objective:
Experts from industry will convene to discuss the history and importance of Bayesian statistical approaches in Chemistry Manufacturing Control (CMC) development and lifecycle of pharmaceuticals. This discussion will address the benefits of using Bayesian statistical approaches to both patients and industry. Stakeholders will exchange knowledge and strategies to enhance understanding and acceptance of Bayesian statistical approaches in pharmaceutical development.
Steering Committee:
- Ben Ahlstrom, Amgen, IQ Consortium CMC Statistics Leadership Group (SLG) Chair
- Charles Tan, Pfizer, USP Statistics Expert Committee Chair
- Perceval Sondag, Novo Nordisk, USP Statistics EC Member
- Svetlana Lyapustina, IQ Consortium SLG
- Katherine Giacoletti, Merck, IQ Consortium SLG
- Ke Wang, Pfizer, IQ Consortium SLG
- Stan Altan, JNJ, IQ Consortium SLG
- Tara Scherder, SynoloStats
Who Should Participate:
- IQ CMC SLG members
- FDA reviewers, both statisticians and non-statisticians
- Academic researchers and students
Reference Materials:
- PowerPoint presentations are currently being finalized and will be made available to participants approximately 2-3 weeks prior to the summit
For further information or to suggest additional stakeholder topics related to USP General Chapters please contact us at gc@usp.org.