Drug delivery technologies are evolving to support the delivery of drugs that balance enhanced safety and efficacy profiles with ease of use. With rapid evolution comes challenges to implementation of new devices and technologies. Existing quality systems, regulatory requirements and guidance’s may need to be revisited and adapted to future delivery technologies.
This session will dive into emerging drug delivery technologies and discuss considerations for implementing holistic control strategies, evaluate impact to Quality systems, and discuss regulatory requirements and pathways for these combination products. Opportunities and hurdles associated with implementing new device technologies within the current Quality and Regulatory systems and processes will be examined.
Questions to be addressed in this session:
• What are some examples of new or emerging novel drug delivery technologies? • What are the differences in the drug versus the device quality systems and what control strategies are employed relative to drugs versus devices and will these need to change as device technology changes? • What regulatory challenges will occur when trying to introduce a new drug delivery technology? Will regulations and guidance’s need to change? How can regulatory updates or changes occur to match the rapid pace of device innovation and facilitate the implementation of new delivery technology that can benefit patients?