Global Harmonization in the Diverging Combination Products Space

Thursday, November 13, 2025

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

Location: Narragansett Ballroom

Moderator(s)

Susan Neadle (she/her/hers)

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

View Slides

Speaker(s)

Ashley Boam (she/her/hers)

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

Director, CMC Policy and Advocacy
GSK, District of Columbia, United States
Subhi Saadeh

Associate Director - MDCP QA
Gilead Sciences
John Weiner

Member
Barr Consulting LLC
Mohammad Alkudsi

Director, Product Classification, Products Classification Department
Saudi Food and Drug Authority (SFDA) (Virtual)

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.