Pre-Conference Workshop Day

Synopsis

Ensuring your combination product meets FDA expectations for Essential Performance Requirements is critical for any sponsor today seeking FDA marketing approval. Navigating the ambiguities and inconsistencies with EPR expectations in the absence of any formal guidance is a pain point for most sponsors. This workshop will introduce the concept of EPRs, share the latest FDA thinking, and provide tips on how to build and execute a sound risk-based strategy to gain FDA buy-in. This workshop will specifically focus on:

• Demystifying the meaning of EPRs and associated FDA expectations
• Identifying the necessary EPRs for your combination product using a risk-based approach
• Developing and executing a test plan to demonstrate your product can reliably meet these EPRs
• Building a sound EPR control strategy to include in your submission package
• Sharing EPR Case studies and lessons learned

Synopsis

Applying human factors throughout device development is important to create a safe, effective, and easy-to-use product. With the

nuances of and challenges posed by the pharmaceutical industry, the path of applying human factors can be anything but linear.

The purpose of this workshop is to delve into how human factors are really applied in combination product development, and to

discuss some potential solutions to applying human factors in complex situations. The topics covered in this session will include:

• Ways in which combination product development most commonly deviates from the standard path of applying human factors
• Tips for promoting human factors during product development as a non-expert
• How to de-risk your validation (i.e., summative) study from the start of product development
• Tools to decide what human factors work can be done, should be done, and must be done
• Solutions to “work smarter, not harder” when it comes to human factors
• Human Factors strategies for “leveraging” previous work and using COTS (commercial off the shelf) materials