USP and the American Association of Pharmaceutical Scientists (AAPS) are sponsoring a workshop on the unique scientific, practical and regulatory challenges in designing and evaluating control strategies for oligonucleotides and peptides throughout the product lifecycle.
- Gain a comprehensive view of current strategies and methods
- Discuss gaps in guidance and technology
- Share your insights to potentially influence future practices
Speakers include experts from industry, FDA, EMA, and USP. Presentation topics include:
- Analytical Methods and Specifications for Peptides – A USP Perspective
Presented by: Dale Schmidt, M.S., U.S. Pharmacopeia (USP)- Development of future monographs based upon their complexity and impurity profiles
- Transition to current monograph methods
- Methods used in early USP peptide documentary standards
- USP Perspective on Reference Standard Development and Uses
Presented by: Fouad Atouf, Ph.D., U.S. Pharmacopeia (USP)- New initiatives in the area of therapeutic synthetic peptides
- Peptide-related documentary and reference standards
- Overview of the USP process for Reference Standard development
Location Information
Sheraton Silver Spring
8777 Georgia Ave
Silver Spring, MD 20910