Summit Workshop:
Combination Products - Foundational Solutions Across the Total Product Lifecycle

Wednesday, September 11, 2019

Your industry colleagues, and expert leaders, will share with you successful solutions for enabling the success of your combination product across the Total Product Lifecycle. These leaders have lived through the combination product industry during a time when there was no regulation (pre-Part 4), when there were no guidances, and when expectations were unclear. These industry colleagues will share with you the important aspects you need to understand to make sure your combination product is safe, effective, meets intended use, and is compliant with the evolving regulatory landscape. Don’t miss this opportunity to learn how other companies are navigating the gray, and how you can improve your processes today!

Register today for this immersive workshop, Wednesday, September 11, 2019, 8:30am-4:00pm at Xavier University.


Workshop Agenda

8:00 AM - 8:30 AM
Join your colleagues from around the globe as we kick off the Combination Products Summit Workshop with a complimentary warm breakfast.

8:30 AM - 8:45 AM
Workshop Welcome
Welcome to the Summit and welcome to Xavier University. This purpose-driven summit will lead you to actionable learning and implementation plans.

8:45 AM - 10:15 AM
The Global Regulatory Landscape for Combination Products
Combination Products requirements continue to evolve globally, with the US and EU taking the lead through formal regulations. During this session, key challenges faced by industry across the markets will be discussed, along with successful practices for you to walk away with. In particular, a strategy for meeting the new EU requirements and planning for pipeline products will be shared, while addressing the emerging interest from countries such as China, Malaysia and Japan. Don’t miss this opportunity to build an effective strategy for your company.

Facilitator: Kirsten Paulson, Senior Director, Global CMC-Medical Device Lead, Pfizer

10:15 AM - 10:30 AM

10:30 AM - 12:00 PM
Human Factors in Combination Products Risk Management
Drug-device combinations with complex controls or unexpected device operation can lead to increased patient risk. Human factors is the scientific discipline concerned with understanding interactions among humans and various system elements, which enables an effective design that promotes human well-being and overall system performance. Participants will benefit from the facilitator sharing case study and successful practice scenarios.

Facilitator: Susan Neadle, Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design, Johnson & Johnson

12:00 pm - 12:45 PM

12:45 pm - 2:15 PM
Post Approval Changes - Understanding When a Change is a “Change”
When is a design change considered a regulatory change? This question plagues many companies, but is critical to understand so your patients are not exposed to increased risk. Through this session, you will be immersed in the diversity of changes, and will understand “when and why” a change is a change. Successful practices will be shared with you that you can implement in your company today.

Facilitators: Lee Leichter, President, P/L Biomedical; John McMichael, Associate Director Combination Products, AstraZeneca; Suzette Roan, Senior Director, Global Regulatory Affairs, Sanofi

2:15 PM - 2:30 PM

2:30 PM - 3:45 PM
Post Market Safety Reporting - End to End Approach
Post Market Safety Reporting Requirements (PMSR) for combination products are not new, but unique just like the combination product itself. While the requirements are simple and expected to follow the primary pathway that the combination product is cleared under or approved as, it is the additional reporting requirements for the other constituent part that add complexity. Operational challenges require an update to the entire end-to-end PMSR process, which become obvious as we build the IT infrastructure to support the system. Learn successful practices and insights you can use in your company.  

Facilitator: Khaudeja Bano, Head of Medical Affairs, Abbott Molecular

3:45 PM - 4:00 PM
Workshop Close



Join us at Xavier University on Wednesday, September 11, 2019, from 8:30am-4:00pm for the “Combination Products - Foundational Solutions Across the Total Product Lifecycle” Workshop. The cost for this immersive experience is $850, but plan on extending your stay to join FDA and your industry colleagues for the entire Xavier Combination Products Summit (the workshop is September 11, summit sessions are September 12-13). For complete information on planning your visit with us, click here.


Workshop Facilitators