Global Harmonization in the Diverging Combination Products Space

Thursday, November 13, 2025

10:20 AM - 11:20 AM East Coast USA Time

Moderator(s)

Susan Neadle (she/her/hers)

Principal Consultant & President
Combination Products Consulting Services, LLC, Florida, United States

Speaker(s)

Ashley Boam (she/her/hers)

Director, Office of Policy for Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER)
FDA, Maryland, United States
Katie Duncan

Director, CMC Policy and Advocacy
GSK
Subhi Saadeh

Associate Director - MDCP QA
Gilead Sciences
JW

John Weiner

Member
Barr Consulting LLC

How do you contend with the disparate and dynamic regulatory frameworks for combination products across jurisdictions globally? In this session, a panel of experts will discuss challenges, opportunities, and glimmers of hope for harmonization in the combination product space. Highlights include review of historical and current efforts to support awareness of the challenges and proposed next steps to drive progress on harmonization.