Pre-Summit Workshop Agenda:
Foundations of Combination Products Agenda Workshop

Monday, September 11, 2017

 

In this foundational workshop, participants were exposed to challenges, expectations and successful practices for management of combination products throughout the total product lifecycle (see full agenda below). Participants were 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.

 

Featured Speakers:


7:45 AM - 8:30 AM

Check-in and Hot Breakfast

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.


8:30 AM - 8:45 AM

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!

Speakers: 

  • Marla Phillips, Xavier University

8:45 AM - 9:45 AM

Setting the Stage

This session will provide information about fundamental combination product issues such as: What are combination products? How will my combination product be regulated? What is a Request for Designation, and is it a good idea?  What is a pre-Request for Designation? What kind of investigation/marketing application will be required for my combination product? How are user fees assessed for combination products? How can I find out more information about combination products? Participants will develop a fundamental understanding of combination products. 

Speakers: 

  • Suzanne O’Shea, Navigant Consulting

9:45 AM - 10:00 AM

Break


10:00 AM - 11:30 AM

Combination Product Development

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).

Speakers: 

  • Susan Neadle, Johnson & Johnson
  • Suzette Roan, Biogen

11:30 AM - 12:15 PM

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.

Speakers: 

  • Susan Neadle, Johnson & Johnson
  • Suzette Roan, Biogen

1:30 PM - 1:45 PM

Break


1:45 PM - 3:15 PM

Post-Market Changes for the Combination Product

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.

Speakers: 

  • Suzanne O’Shea, Director, Navigant Consulting
  • Suzette Roan, Biogen

3:15 PM - 3:30 PM

Break


3:30 PM - 5:00 PM

Post-Market Safety Reporting

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.

Speakers: 

  • Khaudeja Bano, Abbott Diagnostics
  • Susan Neadle, Johnson & Johnson