Dr. Bush will lead a presentation titled, “Drug/Device Combination Products: A Pharmacokinetic Perspective.” As defined by FDA, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. This symposium will also be offered as a webcast and will take place on February 11.
Date: February 11, 2020
Time: 8:45am – 5:00pm | Pacific Time
Location: Foster City Crowne Plaza | 1221 Chess Dr. | Foster City, CA
Registration deadline: February 7 (registration will close if seating cap is reached)
For more information on the workshop and to register for the event:
Other speakers include: Paul Feldman, Ph.D. (Intarcia Therapeutics), Jessica Hawes, Ph.D. (CDER, FDA), Vladimir Bantseev, Ph.D. (Genentech), Christopher Rhodes, Ph.D. (Drug Delivery Experts), James Oberhauser, Ph.D. (Gilead), and Louis-Georges Guy, Ph.D. (AccelLAB)
More About the Topic
The Agency expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH).
As Drug/Device combination products typically involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development, such as preclinical testing, marketing applications, manufacturing and quality control. This symposium will cover some of these challenges faced in the development of drug/device combination products presented by speakers from Industry, FDA and Contract Research Organizations.