Combination Products: Quality & Regulatory Requirements

        Drug-Device Combination Products: Quality & Regulatory Requirements

        7 – 9 October 2025

        1 850 €

        TRAINING TIMES

        13:00 - 16:00   Vienna

        12:00 - 15:00   London

        07:00 - 10:00   New York

        04:00 - 07:00   Los Angeles

        Wi-Fi Icon

        WHY SHOULD YOU ATTEND?

        Understand the regulatory pathway

        Learn how to navigate regulatory expectations for drug-device combinations

         

        Learn to integrate design control

        Get clarity on how to integrate risk analysis, and GSPR requirements into your product development

        Build a compliant control strategy

        Learn to create a clear strategy that aligns clinical, regulatory, and quality components

        Avoid costly delays and rejections

        Learn how to anticipate regulatory expectations early and structure your submission to prevent setbacks during review.

         

        OUR ONLINE TRAINING EXERIENCE INCLUDE

        Live, Interactive Format

        Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

        Full Access via Client Zone

        All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

        Certificate of Completion

        Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.

        LEARNING OBJECTIVES

        Understand global requirements for combination products icon

        Understand global requirements for combination products

        Learn how to navigate both drug and device regulations, including FDA, EMA, and Notified Body pathways

        Align with regulators and internal teams icon

        Align with regulators and internal teams

        Discover how to justify design choices, risk strategies, and documentation that hold up under scrutiny

        Build a compliant control strategy icon

        Build a compliant control strategy

        Develop an integrated plan covering clinical, quality, and design control elements to support product approval

        Avoid costly regulatory pitfalls icon

        Avoid costly regulatory pitfalls

        Spot potential compliance issues early and learn how to prevent delays during review and approval

        WHO IS THIS TRAINING FOR?

        Regulatory Affairs

        Quality Assurance and Control

        Device Engineering & Manufacturing

        Research & Development

        KEY TOPICS

        Understand drug-device and device-drug regulatory pathway

        Apply design control and risk management principles to combination products

        Ensure labeling, GSPR, and QMS alignment

        Plan post-market surveillance and manage ongoing regulatory responsibilities

        TRAINER

        James Pink
        Meet James Pink — a seasoned regulator and recognized authority in quality and risk management for medical devices. With over 25 years of experience, he played a key role in establishing one of Europe’s leading notified bodies. During the COVID-19 pandemic, he was also responsible for scaling up the UK’s national ventilator effort.
        TESTIMONIALS
        It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really
        James is very competent and has complete knowledge of the matter
        Very informative training delivered by a highly skilled SME

        PAST PARTICIPANTS

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        Drug-Device Combination Products: Quality & Regulatory Requirements

        Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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        Online Participation
        1 850 € Price incl. VAT: 1 850 €

        Price per delegate including:

        Online participation

        Online workbook & materials

        Certificate

        PC, microphone, camera, stable internet connection and the Zoom application.

        Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

        Yes, you can transfer the registration to a colleague at any time.

        Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

        Laura Kristensen

        laura.kristensen@symmetric.events
        +421 222 200 543

        Event Details
        • Start Date
          7. October 2025 13:00
        • End Date
          9. October 2025 16:00
        • Email
          laura.kristensen
        Request in-house