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DIA/RAPS Fundamentals of Combination Products: Regulatory and Practical Insights from the US, the EU and Beyond 2026
Dec 9–11, 2026
Online
A three-day introductory virtual workshop from DIA and RAPS on the regulatory landscape for drug-device and biologic-device combination products in the US, the EU and other key markets. Sessions cover product classification and primary mode of action, US pathways and lead center assignment, quality systems and human factors, the EU MDR (Article 117, Rule 14) and notified bodies, and China and global case studies. It carries 12 RAC and 12 RCC credits.
- Program
- 3 tracks · 19 sessions
- 14 speakers
- Organizer
- RAPS
Agenda
Show sessions in
Wed, Dec 9
-
9:00 AM
20 min
Other · The US Regulatory Framework for Combination Products
Welcome Remarks and Introduction
-
9:20 AM
50 min
Talk · The US Regulatory Framework for Combination Products
Introduction - What is a Combination Product in the US? Definitions, Classification, and Primary Mode of Action (PMOA)
Courtney Evans, AbbVie
-
10:10 AM
40 min
Talk · The US Regulatory Framework for Combination Products
US Regulatory Pathways and Lead Center Interactions
Alan Stevens, AbbVie
-
10:50 AM
20 min
Break · The US Regulatory Framework for Combination Products
Break
-
11:10 AM
40 min
Talk · The US Regulatory Framework for Combination Products
Quality Systems (QMS Regulation), Risk Management, and Human Factors for US Combination Products
-
11:50 AM
40 min
Talk · The US Regulatory Framework for Combination Products
US Case Study
Jerzy Wojcik, EdgeOne Medical
Thu, Dec 10
-
9:00 AM
5 min
Other · Foundations of Combination Products in the EU
Welcome Remarks
-
9:05 AM
50 min
Talk · Foundations of Combination Products in the EU
Introduction to Integral Combination Products in the EU: EU Regulatory Framework and Medical Device Regulation (MDR)
Gert Bos, QServe Group
-
9:55 AM
35 min
Talk · Foundations of Combination Products in the EU
The MDR – Implications and Experiences with Art. 117 and Rule 14
Andreas Emmendoerffer, Roche
-
10:30 AM
30 min
Break · Foundations of Combination Products in the EU
Break
-
11:00 AM
40 min
Talk · Foundations of Combination Products in the EU
The Role and Experiences of the Regulator
-
11:40 AM
30 min
Talk · Foundations of Combination Products in the EU
Understanding the Role of Notified Bodies in Europe for Combination Products. NBOp Requirements and Feedback for Manufacturers
Jonathan Sutch, BSI Group
-
12:10 PM
20 min
Talk · Foundations of Combination Products in the EU
EU Case Study
Fri, Dec 11
-
9:00 AM
5 min
Other · Global Perspectives, Practical Insights and Exercises
Welcome Remarks
-
9:05 AM
50 min
Talk · Global Perspectives, Practical Insights and Exercises
China Combination Product Regulatory Review
Sophia Li, AbbVie
-
9:55 AM
40 min
Talk · Global Perspectives, Practical Insights and Exercises
Pharmaceutical Case Studies
Ryan Mcgowan, AstraZeneca Rumi Young, Novo Nordisk
-
10:35 AM
15 min
Break · Global Perspectives, Practical Insights and Exercises
Break
-
10:50 AM
40 min
Talk · Global Perspectives, Practical Insights and Exercises
Medical Technology Case Study
Adam Cargill, Veeva
-
11:30 AM
60 min
Fireside chat · Global Perspectives, Practical Insights and Exercises
Fireside Chat: What Regulators and Notified Bodies Want to See – A First-Hand Perspective
James Bertram, FDA Christelle Bouygues, European Medicines Agency (EMA)
Speakers
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CSL Behring
-
AbbVie
-
AbbVie
-
EdgeOne Medical
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QServe Group
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Roche
-
BSI Group
-
AbbVie
-
AstraZeneca
-
Novo Nordisk
-
Veeva
-
FDA
-
European Medicines Agency (EMA)
From $255
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