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Registration Now Open for FDA-CRCG Workshop:
Navigating the GLP-1 Generic Drug Pathway
Join the FDA and CRCG for the
on September 23-24, 2026
THIS WORKSHOP IS FREE TO ATTEND VIRTUALLY
Are you looking to deepen your understanding of regulatory science, innovative analytical approaches, and development strategies for generic GLP-1 drug products? This 2-day hybrid workshop brings together FDA, industry, consulting groups and academic experts to address regulatory challenges and to explore the latest scientific advancements shaping the development of generic GLP-1 products across diverse therapeutic areas.
Through a series of presentations and interactive discussions, participants will examine regulatory pathways and clinical contexts for generic GLP-1 products, explore characterization and sameness demonstration strategies, and delve into recombinant peptide manufacturing and host cell impurity characterization and control. The program will also address critical challenges such as Product-Specific Guidance (PSG) development, bioequivalence study design and quality expectations for oral and injectable generic GLP-1 products, device user interface evaluation and considerations for supporting other design differences, and drug-device integration and submission coordination, equipping attendees with the knowledge needed to navigate the regulatory landscape.
Choose your experience:
- Virtual: Access expert presentations and panel discussions from anywhere.
- In-person: Interact directly with experts from industry, consulting groups, academia and FDA to understand current practices and challenges, regulatory expectations, and emerging trends. Registration fee applies.
The in-person component will take place at The Universities at Shady Grove, Rockville, MD. High-engagement scientific interactions will be facilitated through two in-person-only sessions:
- A session dedicated to informal networking and candid dialogue among subject matter experts about scientific and regulatory challenges for generic GLP-1 products including sections focused on:
- Device constituents of drug-device combination products
- Impurities and immunogenicity
- GLP-1 characterization and sameness
- Orally administered peptides
- A guided session for small groups to elucidate and work through specific challenging issues for generic GLP-1 products development and assessment.
Don’t miss this opportunity to advance your expertise, network with leading professionals, and help shape the future of generics.
For more information, visit https://www.complexgenerics.org/education-training/navigating-the-glp-1-generic-drug-pathway/
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