A summit focused on solutions for a dynamic industry with evolving regulations.

Combination Products Summit 2022

A summit focused on solutions for a dynamic industry with evolving regulations.


The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Heath’s legacy of delivering the Combination Products Summit. 

The AFDO/RAPS Healthcare Products Collaborative combination products community continues to be led by top FDA officials and worldwide industry leaders who built the framework for the regulatory landscape of combination products. This global community drives innovation and navigates the complexities specific to the world of combination products, resulting in the delivery of safe, effective, and high-quality products to the patients who need them. 

And all of these exciting discussions come to life at the Combination Products Summit! 


Location

Sonesta Columbus Downtown ↗
33 East Nationwide Blvd, Columbus, OH, 43215

Hotel Booking:
Regular Attendee ↗
Government Attendee ↗


Featured Speakers

Thinh Nguyen

Director, Office of Combination Products, FDA-OCP (Invited)

John “Barr” Weiner

Associate Director for Policy in FDA’s Office of Combination Products, FDA (Invited)

Alan Stevens

Assistant Division Director, Division of Drug Delivery and General Hospital Devices and Human Factors, CDRH, FDA

Annie Saha

Assistant Director, Digital Health Center of Excellence, FDA

Jason Lipman

Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi

Khaudeja Bano

Vice President Combination Product Quality, Amgen

Kate Gillespie

Senior Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson

Richard Wolf

Head of Pv Operations at CSL Behring, CSL Behring

James Wabby

Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Combination Products and Devices, AbbVie

FDA Office Hours :
Meet privately with FDA Officials:

Thinh Nguyen

Director, Office of
Combination Products, FDA-OCP (Invited)

John “Barr” Weiner

Associate Director for Policy in FDA’s
Office of Combination Products, FDA (Invited)

Monday, November 7,
10 A.M. – 2:00 P.M.
Registered attendees only


Engage on Hot Topics

1

From the Desk of the Office of Combination Products – Strategic Priorities

2

EU MDR – What is “Significant Change” and What You Need to Know About Notified Body Opinions

3

Use of Medical Devices and Digital Health Technologies in Drug Programs

4

FDA Fireside Chat – A panel of all FDA speakers take your questions


Combination Products Sponsors 2022
Thank you!

Gold Sponsors

Eli Lilly and Company

Silver Sponsors

Summit 2022 Sponsorship Opportunities

Because of the generosity of our sponsors, we can continue our work to innovate in the combination products industry. We invite you and your organization to support this important event.

Meet The New Conference Facilitators

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Health’s legacy of delivering the MedCon Conference.

“Almost a perfect meeting of minds between academia, regulatory agencies, and industry thought leaders to serve the only purpose – safety and public health in combination products.”


— Khaudeja Bano, M.D., Executive Medical Director, Combination Product Safety Head, Global Patient Safety, GRAAS, Research and Development, Amgen