Combination Products Summit 2025 has been announced!

November 13-14, 2025

Providence, RI

AFDO RAPS Healthcare Products Collaborative
Presents
Combination Products Summit

Combination Products Summit took place October 9-10, 2024

Providence, RI

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See you next year at Combination Products Summit 2025

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.

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Combination Products Summit 2024 consisted of …

240

attendees

10

countries

5

continents

14

sessions

14

moderators

33

speakers

17

FDA speakers

19

FDA participants

Combination Products Summit 2024 took place in Providence, RI – driving 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!”

Amaya Hodges Jonathan

Jonathan Amaya-Hodges

Director, Technical Services, Suttons Creek Inc.

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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.

Thank you for joining us.

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 2024 event featured a full-day workshop followed by an in-depth conference. 

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.

Why attend the Combination Products Summit 2025?

Featured Speakers From 2024

James
Bertram

FDA

Isabelle
Clamou

European Commission

Andrew
Fine

FDA

Chelsea
O’Connell

Amgen

Alan
Stevens

AbbVie, Inc.

Hot topics we explored during our previous summit:

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

All current RAC holders 

Earned 12.0 RAC recertification credits by attending the summit. 

Sponsors from the 2024 Summit

Because of the generosity of our sponsors, we can continue our work to improve the healthcare products industry and patient care.

Lilly - Sponsor
Sutton Creek - Sponsor
RQM - Sponsor
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Basil Systems - Sponsor
Patrick Flynn

Learn more about supporting Combination Products Summit through sponsorship by contacting Patrick Flynn at +1 (301) 770-2920, ext. 246, or pflynn@raps.org.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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© 2024 AFDO/RAPS Healthcare Products Collaborative