Back to News

USP/IQ Summit: Bayesian Approaches in Chemistry Manufacturing Control (CMC) - 10 December

Register Now! Seating is limited!

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:

• Summit Agenda
• PowerPoint presentations are currently being finalized and will be made available to participants approximately 2-3 weeks prior to the summit

Contact M. Patricia Gaitan at MPG@usp.org for registration or logistical assistance.