Combination Products Summit 2025

Driving Engagement and Exploring Innovation for Combination Products

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Presented by

Presented by AFDO RAPS Healthcare Products Collaborative

Workshop

2025 Pre-Conference Workshop

Navigating Industry Trends: Hot Topics, Regulatory Best Practices, and Drug Delivery Strategies

This Pre-Summit Workshop will address current and emerging hot topics impacting the industry, best practices for optimizing combination product regulatory submissions and development programs, and strategies for establishing drug delivery performance (e.g. essential drug delivery outputs).

Hot Topics Q&A

Regulatory submissions and development programs best practices

Strategies for establishing drug delivery performance

Each session explores important issues and approaches on dealing with combination products. Participants will increase their knowledge and diversify their learning!

Please note – this workshop requires a separate registration fee and is not part of the main Summit.

Please check back for additional session and speaker information to be announced soon.

2024 Pre-Conference workshop Facilitators

Ryan
Hoshi

AbbVie, Inc.

Director, Regulatory Policy and Intelligence

Jason
Lipman

Sanofi

Senior Director, Global Regulatory Affairs, Device and Combination Products

Ryan
McGowan

AstraZeneca

Director, Digital Devices and Combination Products

Hemal
Mehta

Johnson & Johnson

Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products

Chin-Wei
Soo

Genentech/Roche

Vice President Regulatory Head, Devices and Combination Products

James
Wabby

AbbVie, Inc.

Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow – Regulatory Science

About AFDO/RAPS Healthcare Products Collaborative

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