Combination Products: Notified Body Opinion Process

        Drug-Device Combination Products: Notified Body Opinion Process

        11 – 13 November 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?

        Plan For a Successful NBO

        You will gain a comprehensive overview of the NB application and review process and understand where their responsibility begins and ends. Using live examples, you will learn how to apply GSPRs and standards to achieve a good submission.

        Apply the Resources at Your Disposal

        You will learn how to apply standards and use GSPRs to generate evidence that meets expectations. All this will be demonstrated through live use of resources and on real products such as a transdermal patch, an autoinjector, and more.

        Highly Interactive Live Format

        The workshop is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!). We activate participants with live walkthroughs, discussions and on-the-spot problem solving. 

        Trusted by Industry Leaders

        This workshop has a long history, consistent highly positive feedback and has evolved over time thanks to feedback from companies such as Biogen, Novartis, Novo Nordisk, Lonza, Leo Pharma and many others.

        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

        Notified Body Application icon

        Notified Body Application

        Gain a comprehensive overview of the application and review process. Understand where the responsibility begins and ends.

        Standards icon

        Standards

        Apply ISO 13485 and 11608 to achieve a good submission

        General Safety and Performance Requirements icon

        General Safety and Performance Requirements

        Using the GSPR checklist to manage your design and development file

        Generating Evidence icon

        Generating Evidence

        Understanding risks, requirements, and standards in the context of evidence

        Design Control icon

        Design Control

        Design and development activities necessary for a successful NBO

        WHO IS THIS TRAINING FOR?

        Regulatory Affaris

        Quality Assurance & Control

        Device Engineering & Manufacturing

        Research & Development

        KEY TOPICS

        Notified Body application & review process

        Regulatory requirements: EU MDR, Annex 1, IVDR

        ISO 13485 & ISO 11608

        General Safety and Performance Requirements

        CE marking

        Design and Development File

        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: Notified Body Opinion Process

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

        Share This Event
        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
          11. November 2025 13:00
        • End Date
          13. November 2025 16:00
        • Email
          laura.kristensen
        Request in-house