A summit focused on solutions for a dynamic industry with evolving regulations.
Combination Products Summit
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!
Past Speakers
Thinh Nguyen
Director, Office of Combination Products, FDA-OCP
John “Barr” Weiner
Associate Director for Policy in FDA’s Office of Combination Products, FDA
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
Hot topics from the 2022 conference:
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
Silver Sponsors
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