AFDO RAPS Healthcare Products Collaborative
Presents
2024 Combo Logo FDA
Register now

Workshop

theme

Delving into Combination Product Challenges

In this dynamic pre-Summit day, we will explore crucial issues affecting combination products today. The day will consist of three interactive sessions on:

Digital health technologies

Aligning risk management approaches

Hot Topics Q&A

Each session will explore important issues and approaches to dealing with combination products. Prepare to increase your knowledge and diversify your learning!

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

Don’t miss this opportunity to engage with thought leaders who have had significant impact on the global discussion around these topics!

Moderators

Chin-Wei
Soo

Genentech/Roche

Global Regulatory Head – Devices and Combination Products

Hemal
Mehta

Johnson & Johnson

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

James
Wabby

AbbVie

Global Head – Emerging Technologies, Combination Products, and Devices

Jason
Lipman

Sanofi

Senior Director, Global Regulatory Affairs, Device and Combination Products

Ryan
Hoshi

AbbVie

Director, Regulatory Policy and Intelligence

Ryan
McGowan

AstraZeneca

Director, Digital Devices and Combination Products

Susan
Neadle

Combination Products Consulting

Principal Consultant & President

October 8th, 2024 — Combination Products Summit Workshop Agenda

October 8, 2024 @ 9:00 am

12:00 pm

Digital Health Technologies and Combination Products Sessions

Digital Health Technologies are increasingly used in the development, manufacturing, investigation, marketing, and maintenance of combination products. This focused session will cover a range of digital health topics that are relevant to development, quality, regulatory, and patient safety functions that support combination products.

Intro: Future of Digital Health

Session 1: Digital Health Technologies for Remote Data Acquisition

Session 2: Artificial Intelligence and Machine Learning

Session 3: Mobile Medical Device Applications

Moderators

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Ryan Hoshi, Director, Regulatory Policy and Intelligence, AbbVie

Chin Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech

Speakers

Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVIE
Anchal Choudhuri, Senior Consultant, Biologics Consulting
Erez Kaminski, CEO & Founder Ketryx
Elizabeth Kunkoski, Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER), FDA
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epistein, Becker and Green
Eric Staib, Vice President, Corporate Quality, Syneos Health
Brandi Stockton, Managing Partner, Triality Group
Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

October 8, 2024 @ 12:00 pm

1:00 pm

Lunch

October 8, 2024 @ 1:00 pm

3:00 pm

Aligning Risk Management Approaches Between Sponsors, Suppliers, and CDMOs

Sponsors, suppliers, and CDMOs may not all use consistent risk management approaches. This is a significant challenge in the combination product space, where most sponsors are dependent upon a third party for at least one critical aspect of the development and/or lifecycle management process. This session will discuss some of the challenges and opportunities and provide a framework for success.

Moderator

TBD

Panelist

TBD

Facilitators

Susan Neadle, Principal Consultant & President, Combination Products Consulting, LLC
James Wabby, Head – Global Regulatory Affairs, Emerging Technologies, Combination Products, and Devices, AbbVie Inc.

Speakers

Carolyn Dorgan, Director, Technical Services, Suttons Creek, Inc. 
Laxman Halleppanavar, Head of Project Management, Credence Med
Jerzy Wojcik, VP Regulatory and Quality Services, Edgeone Medical (CDMO)

October 8, 2024 @ 3:00 pm

3:15 pm

Break

October 8, 2024 @ 3:15 pm

5:15 pm

Hot Topics for Combination Products

Come join in the fun and engage with a panel of combination product regulatory experts from across industry as they share approaches, strategies, and case studies on key regulatory topics. This will be a lively, interactive, and collaborative session. The discussion will span a range of topics including CP development and submission strategy from clinical to post-market, including strategies and approaches related to clinical studies, clinical bridging, phase-appropriate testing, human factors, control strategies, and more.

Facilitators

Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi

Hemal Mehta, Associate Director, Global CMC Regulatory Affairs, Medical Devices & Combination, Johnson & Johnson

Speakers

Nish Gupta, Senior Regultory Program Director, Genentech
Willy Liou, Director of Regulatory Affairs, Amgen
Amanda Matthews, Senior Director, Regulatory CMC for Combination Products and Medical Devices, Pfizer
John McMichael, Director, Medical Devices & Combination Products, AstraZeneca
Abhishek Telang, Principal Scientist, Merck
Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Lilly
Suzette Roan, Associate VP, Head of GRA Devices, Sanofi

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.

Newsletter

Stay in the know about upcoming events and breaking news from the collaborative.

Subscribe

ContACT

Have questions about our events or how to get involved with one of our committees or workgroups?

Get in touch

© 2024 AFDO/RAPS Healthcare Products Collaborative