A Summit Focused on Solutions for a Dynamic Industry With Evolving Regulations
Since 2015, the Combination Products Summit has united the healthcare products industry to work for a better tomorrow. The community continues to be led by top regulatory officials and worldwide industry leaders who built the framework for the regulatory landscape of combination products.
200+ participants
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5
16
60
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Combination Products 2024 convenes October 9th – 10th in Providence, RI to drive innovation and navigate 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.
“If your work has anything to do with combination products, you should be here!”
Jonathan Amaya-Hodges
Director, Technical Services, Suttons Creek Inc.
FDA Office Hours
October 8, 2024 | 10 a.m. to 2 p.m.
In a 15-minute conversation, you and your team will have the opportunity to ask your questions, discuss your challenges, and gain the perspective of the FDA’s top combination product officials.
Join us in Providence this October for Combination Products 2024
Hosted by AFDO/RAPS Healthcare Products Collaborative and co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services, the event features a full-day pre-conference workshop* on October 8th followed by an in-depth conference on October 9th -10th.
(*separate registration required for the workshop)
One-on-one meetings with FDA executives during FDA Office Hours to ask questions, discuss challenges, and gain new perspectives from top officials
Interactive presentations and vital networking opportunities that explore solutions for a dynamic industry in an ever-changing regulatory landscape
Participation in sessions, informal collaboration, and networking events focused on what’s new and what’s next for combination products
Don’t miss the chance to engage in actionable learning and implementation plans for combination products.
2024 Featured Speakers
James
Bertram
FDA
Isabelle
Clamou
European Commission
Andrew
Fine
FDA
Chelsea
O’Connell
Amgen
Alan
Stevens
AbbVie
Join Us to Explore These Hot Topics (and so much more)
From the Desk of the FDA Office of Combination Products – Strategic Priorities
Aligning Device Constituent Parts With Drug CMC Review Principles
Harmonizing U.S. FDA’s QMSR to ISO 13485: Impact to Combination Products
Challenges of Complex Generic DDCP Development and Assessment
Opportunities for Platform Technologies to Streamline Combination Product Development
Regulatory and Technical Considerations for On-Body Delivery Systems (OBDS)
Building Your Combination Product – Taking the Leap from Clinical to Commercial
The EU COMBINE Project: Medical Devices and IVDs Used in Medicinal Product Studies
Innovative Combination Products for the Next Generation of Medicine
Are you a current RAC holder?
Attend Combination Products Summit 2024 and earn 12.0 RAC recertification credits.
2024 Summit Sponsors
Because of the generosity of our sponsors, we can continue our work to improve the healthcare products industry and patient care.
Gold Sponsor
Silver Sponsor
Leader Sponsor
Learn more about supporting Combination Products Summit 2024 through sponsorship by contacting Patrick Flynn at +1 (301) 770-2920, ext. 246, or pflynn@raps.org.