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#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
203AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-588-L04-P; CME 1.00; RN 1.00

Explore the latest combination product trends, sustainability in design, recent FDA/global guidelines, post-approval device changes, and emerging submission practices to help navigate the evolving regulatory landscape and achieve development success.

Learning Objectives

Discuss recent FDA and global guidelines (ICH Q1, ICH Q6, ICH M4Q) that inform effective control strategies & stability programs; Recognize how to manage post-approval changes for device constituents and focusing on best practices; State recent IND and submission trends (e.g., Human Factors, design verification, stability) and successful health authority interactions to accelerate therapies to patients.

Chair

Rumi Raquel Young, MS

Speaker

Panelist
Alan Stevens, MS

Panelist
James Bertram, PHD, MS, RAC

Panelist
Chelsea O'Connell, MS, RAC

Panelist
Katie Duncan, PHD


Speakers
avatar for James Bertram

James Bertram

Director, Office of Combination Products, OC, FDA, United States
James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective... Read More →
KD

Katie Duncan

Director, CMC Policy and Advocacy, GSK, United States
Katie Duncan is a Director of CMC Policy and Advocacy with Global Regulatory Affairs/CMC Excellence. Prior to joining GSK, Katie was a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality at the US Food and Drug Administration. She previously worked in... Read More →
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently US Lead, Global Regulatory Policy & Intelligence, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various... Read More →
AS

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States
Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for... Read More →
avatar for Rumi Young

Rumi Young

Director, Regulatory Policy, Novo Nordisk A/S, United States
Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

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