Get ready to explore the complete development pathway for generic glucagon-like peptide-1 (GLP-1) products, encompassing topics from peptide active pharmaceutical ingredient (API) characterization through device design and patient delivery.
The Center for Research on Complex Generics (CRCG) and the U.S. Food and Drug Administration (FDA) are hosting a comprehensive workshop Sept. 23-24 at the Universities at Shady Grove and virtually that will address the unique scientific, regulatory, and technical challenges in developing generic GLP-1 products.
The workshop will provide in-depth insights into every stage of generic GLP-1 development. Through a series of presentations, panel discussions, and interactive sessions, attendees will gain a deeper understanding of:
- Regulatory pathways and clinical contexts for GLP-1 products (505(j) vs 505(b)(2))
- API characterization, sameness demonstration, and analytical strategies for peptides
- Recombinant peptide manufacturing and host cell impurity control
- Product-Specific Guidance (PSG) development, bioequivalence study design, and quality expectations for oral GLP-1 products
- Device user interface evaluation and Comparative Use Human Factors (CUHF) studies
- Drug-device integration, quality control, and submission coordination
Join leading experts from the FDA, industry (innovator and generic companies, as well as device manufacturers), and academia as we navigate the complex landscape of generic GLP-1 product development. Whether you're a regulatory professional, pharmaceutical scientist, formulation expert, device engineer, human factors specialist, or academic researcher, this workshop offers invaluable insights into developing these complex generic products. Don't miss this opportunity to advance your understanding of generic GLP-1 development.
Register now and join the conversation on the future of generic GLP-1 products.
Registration Fees
- This workshop is FREE for virtual attendees
- The combined cost for the two-day workshop in-person attendance and activities is:
- $350, in-person attendees — general
- $150, in-person attendees — government (must have an email ending in “.gov” to register at this rate)
For UMB faculty, staff, and students, please email CRCG at info@complexgenerics.org regarding registration.