In this foundational workshop, participants will be exposed to challenges, expectations and successful practices for management of combination products throughout the total product lifecycle. Participants will be able to:
Understand the intricacies of the US and EU approaches to combination products.
Successfully develop combination products by understanding the similarities, differences, and areas of overlap from the key aspects of drug development and device development requirements.
Establish a framework to determine what types of post-market changes require what type of regulatory approval.
Successfully navigate Post-Market Safety reporting expectations through an understanding of challenges and best practices from across the industry.
Participants will have an opportunity to enjoy a hot breakfast with workshop leaders and their colleagues from across the industry in our comfortable and collaborative setting.
Welcome and Introductions
Welcome to Xavier University and welcome to the Combination Products Foundations Workshop. Through our mission of inspiring collaboration, leading innovation, and making a difference, we look forward to making a difference in your life. Thank you for joining us!
As simple as it sounds, the question of “what is a combination product” is an intricate question filled with many complexities that the workshop leaders will explore with participants. To set the stage, the US approach to combination products (lead center, role of the Office of Combination Products, Request for Designation, and meetings with FDA) will be compared to the EU approach to combination products (current directives, implications of the new medical device reports, scientific advice, and marketing authorization applications) such that participants will have a clear understanding of what is necessary for a successful global strategy.
Key aspects of the drug development process and of the device development process will be shared with participants. Workshop leaders will then examine with participants the areas of overlap that occur in the development process for a combination product, including similarities, differences, and challenges. (This session will be continued after lunch)
Participants will have an opportunity to enjoy a wonderful lunch while discussing their questions and ideas with workshop leaders and their colleagues in our comfortable and collaborative setting
12:15 PM - 1:30 PM
Combination Product Development (continued)
(This session from before lunch is continued here). Key aspects of the drug development process and of the device development process will be shared with participants. Workshop leaders will then examine with participants the areas of overlap that occur in the development process for a combination product, including similarities, differences, and challenges.
The differences in post-market change approval requirements for drugs and devices will be assessed as various types of changes are examined. A framework of understanding will be established that will allow participants to navigate uncertainties in post-market change approvals for combination products.
Expectations, challenges and best practices will be shared with participants related to the post-market safety reporting requirements and expectations related to drug primary mode of action (PMOA) and device PMOA combination products. Participants will be armed with examples they can apply for successful practices in their organizations.