Introduction to Regulatory Affairs for Regenerative Medicine
Complimentary Online Course
Date: November 21, 2025
Time: 12:30–1:45 PM ET
Location: Live Online (Zoom)
Cost: Complimentary
Instructor: Steven R. Bauer, PhD
What You’ll Learn
Explore how the FDA regulates regenerative medicine products—from early development through approval and post-market safety.
Dr. Bauer will outline key laws, regulations, and guidance shaping the field and discuss scientific challenges like manufacturing consistency and cellular heterogeneity. Learn how improved characterization methods and standards can accelerate safe, effective therapies to patients.
Key Takeaways
- Understand FDA pathways for cell, gene, and tissue-engineered products.
- Learn practical strategies for addressing variability in manufacturing.
- Gain insight into regulatory expectations for product development.
- Explore best practices for engaging with the FDA from pre-IND through licensure.
The Instructor
Steven R. Bauer, PhD
Chief Regulatory Affairs Officer, WFIRM
Dr. Bauer is currently a regulatory science advisor in the Regenerative Medicine Hub at Wake Forest Institute for Regenerative Medicine (WFIRM). Before joining WFIRM, he spent three decades at the U.S. Food and Drug Administration (FDA) in regulatory science research, regulatory submission review, policy development, and standards development for regenerative medicine products.
Who Should Attend
- Scientists, engineers, and clinicians working with cell, gene, or tissue-engineered products
- Startup founders and product managers planning FDA interactions
- Manufacturing, quality, and regulatory professionals new to regenerative medicine
- Students and trainees seeking a practical orientation to FDA pathways