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

• Krishna Venugopalan, Vice President, CPD & DD, BioCMC Development Sciences, AbbVie
• Carolyn Dorgan, Combination Product Development, Regulatory and Quality Consulting, Suttons Creek
• Sujith Kallur, Regulatory Affairs Manager, BD
• Juliane Lessard, Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Center for Devices and Radiological Health (CDRH), FDA