The FDA started to address Drug Delivery Systems as combination products almost 20 years ago and have more recently instituted a growing number of unique ways to regulate the development, registration and control of these products. To make issues more complicated, there are an increasing number of regions that are also starting to treat these products differently. One of these examples is the upcoming Medical Device Regulation (MDR) to be considered also for Drug Device Combinations in Europe. Independent of the regulations, the number, scope and complexity of these products is expanding exponentially.
This workshop will provide attendees with insight into the challenges, and potential solutions to dealing with the requirements and regulations related to the development, registration and control of Drug Delivery Systems. The workshop will include speakers from regulators and industry and allow interactive audience participation with panels of experts on each issue to provide a forum for information and discussion on navigating the challenges presented by these products.