USP/AAPS Workshop on Development of Control Strategies for Oligonucleotides and Peptides: Regulatory and Industry Perspectives

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

Registration Agenda

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