Combination products continue to transform healthcare by integrating drugs, biologics, and medical devices into innovative therapies that improve patient outcomes. This three-day introductory workshop provides a practical foundation for understanding the regulatory landscape governing combination products in the US, European Union, and key global markets. As these products become increasingly common, regulatory professionals must navigate complex, evolving requirements that span multiple regulatory frameworks, quality systems, and development pathways.
Through expert-led presentations, real-world case studies, regulator and industry perspectives, and interactive discussions, participants will gain a comprehensive understanding of product classification, regulatory pathways, quality and human factors considerations, Medical Device Regulation (MDR) requirements, notified body interactions, and global development strategies. Whether you are new to combination products or looking to strengthen your foundational knowledge, this workshop will equip you with practical insights and tools to support successful global development and regulatory submissions.
Learning Objectives
At the completion of this workshop, attendees will be able to:
- Explain the fundamental characteristics of combination products and how they are classified in the US and EU.
- Describe US regulatory pathways, primary mode of action (PMOA), and lead center assignment considerations.
- Understand key quality system, risk management, human factors, and regulatory requirements applicable to combination products.
- Interpret the European regulatory framework, including the Medical Device Regulation (MDR), Article 117, Rule 14, and the role of notified bodies.
- Compare regulatory expectations across major global markets, including the US, EU, and ASEAN.
- Apply lessons learned from industry case studies to common regulatory and development challenges.
- Recognize strategies for planning global development and regulatory submissions for combination products.
- Identify practical considerations that facilitate successful interactions with regulators and notified bodies throughout product development.
Who Should Attend?
- Regulatory Affairs, Strategy, and Policy professionals
- Medical Device, Pharmaceutical, and Biopharmaceutical Regulatory professionals
- Combination Product teams
- Clinical Development professionals
- Quality, Risk Management, and Human Factors professionals
- R&D, Product Development, and Program Management professionals
- Manufacturing and CMC professionals
- Medical Affairs professionals
- Regulatory consultants
- Representatives from health authorities and notified bodies
- Professionals transitioning into combination product regulatory roles
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
To be determined