Summary
In this virtual workshop, industry, academic, and regulatory experts will share foundational knowledge and critical information of subcutaneous (SC) delivered products, including current regulatory strategies and future directions of SC delivery and products, with specific emphasis on clinical development and regulatory paths. You will leave this event with an understanding of the state of the art/field and how to roadmap your programs moving forward in this ever-evolving landscape
Learning Objectives:
- Learn which formulations and technologies exist to facilitate SC delivery
- Learn how to develop evidence packages for regulatory review
- Determine which regulatory paths are most appropriate to gain regulatory approval
Programming Committee
Tyler DiStefano, Ph.D., Charles River Associates
Nicholas Wechter, MS, Charles River Associates
Tina Morris, Ph.D., AAPS
David Cipolla, Ph.D., Insmed