Building Clarity to Address Regulatory Challenges of On-Body Delivery

On-body delivery systems are an area of increasing interest and development. Over the last few years more of these combination products have been approved for use in the market. This has raised questions from various members in the industry about regulatory and technical challenges and best practice expectations going forward. This session will be an opportunity to level-set the audience on the basic technical and regulatory differences between injection and infusion versions and conduct an interactive panel session to answer industry questions on the subject.

Moderator

• Fran DeGrazio, Executive Advisor, Kymanox

Speakers

• Carolyn Dorgan, Director, Technical Services, Suttons Creek
• Sujith Kallur, Regulatory Affairs Lead, Wearable Injectors, BD Medical Pharmaceutical Systems
• Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA
• Krishna Venugopalan, Vice President – Combination Products, Drug Delivery and Sterile Packaging, AbbVie