This month, Bold Insight Managing Partner Korey Johnson will present at the 15th Annual Pre-Filled Syringes and Injectable Drug Devices Conference. The conference will explore the exciting advances in the combination-product drug delivery space and offer a future outlook exploring how pharma, device developers, and regulators can work together to encourage innovation.
In his presentation, Document improvements to your instructions for use with this framework, Johnson will propose a framework to help drug-delivery device manufacturers understand and anticipate regulator requests and recommendations for submissions of combination products’ labeling and instructions for use (IFUs).
“Understanding regulator requests and recommendations is made far easier with proper context of the human factors protocols and best practices that drive the evaluation of a combination product’s labeling and IFU content and design,” said Johnson. “This framework allows for a systematic assessment of IFUs and product labeling to help manufacturers document design changes and facilitate productive cross-functional discussions with team members, including regulatory.”
The Pre-Filled Syringes and Injectable Drug Devices Conference will take place in person in London, United Kingdom. Johnson’s presentation will take place on January 12, 2023, at 3:50 GMT. Visit the event website to register and learn more about the event.