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2023 Combo Products Summit Agenda

session

Building Clarity To Address Regulatory Challenges Of On-Body Delivery

November 30, 2023 @ 9:15 am

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10:05 am

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

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.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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