Drug-Device Combination Products: Notified Body Opinion Process

        2024 Dates TBC, live online training

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        Summary

        This three-day course will give you a thorough understanding of the Notified Body application process as well as a comprehensive regulatory update. You will understand the responsibilities of the of Notified Bodies.

        Learning Objectives

        • Gain a comprehensive overview of the NB application process
        • Understand where the NB responsibility starts and ends
        • Design and development activities necessary for a successful NBO
        • Why EN ISO13485:2016 will help achieve a good submission
        • Understanding risks, requirements, and standards in the context of generating evidence of conformity
        • Using the GSPR checklist as a means to manage your design and development file

        Key Topics

        • Notified Body (NB) application & review process
        • Regulatory requirements (EU MDR)
        • EN ISO13485:2016
        • General Safety and Performance Requirements (GSPR)
        • CE marking

        Who should attend?

        This course is suitable for all those involved in:

        • Regulatory Affairs
        • Quality Control/ Assurance/ Engineering
        • Product Development/ Engineering/ Technology Transfer
        • Process Development
        • Research & Development

        Past participants

        • Global Head External Quality, Biogen
        • QA Manager, F. Hoffmann-La Roche
        • Senior Manager GLP/GMP, Merz Pharmaceuticals
        • Senior Technical Regulatory Affairs Manager, Idorsia Pharmaceuticals
        • Senior Technical Steward Devices, Novartis
        • Manager, External Manufacturing Management, Ferring 
        • R&D Engineer, Cook Medical
        • Principle Scientist Lead Combination Products, Lonza
        • Process Engineer, Novo Nordisk
        • Quality Manager, Boston Scientific
        • Global DRA Project Leader, Idorsia Pharmaceuticals
        • Design Team Manager, Owen Mumford
        • Development Engineer, Leo Pharma
        • Regulatory Affairs Manager, Novavax
        • Head of Regulatory Affairs, Vectura

        Our online training experience includes

        • Our client zone – a single source for all training materials as well as pre and post-training communication
        • Live interactive format via the Zoom platform
        • Direct interaction with the trainer
        • Q&As, case studies, polls
        • Revisit recorded sessions for 7 days
        • Training in digital format
        • Digital and LinkedIn certificates

        Trainers

        James Pink
        James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body.

        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.

        See the full training agenda
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        ONLINE PARTICIPATION
        1 850 € Price incl. VAT: 1 850 €
        Equivalent of approx. 2 073 USD.
        The price calculation in USD is informative and might slightly differ from your bank exchange rate        .

        Price per delegate including:

        Online participation

        Recorded sessions for 7 days

        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.

        pharma learning leader

        Lydia Makori

        l.makori@symmetric.events
        +421 222 200 543

        Training Details
        Request in-house
        What participants said about Symmetric courses

        "I was happily pleased with the enormous experience of the trainer, i enjoyed it a lot and learned a lot."
        Senior Development Pharmacist, Orion Corporation

        "Keep up the excellent standard of training courses!"
        FDF Industrialisation Manager, Medichem Manufacturing

        "I have received a lot of knowledge that will be of big use for my profession."
        Quality manager, Vironova AB

        "Thank you for a very informative training course. The timing of start/break/finish was perfect."
        Clinical Project Manager, Regen Lab

        "Would highly recommend this course, great practical insights throughout helped to make it all very real, many thanks."
        Head of API and Contract Manufacturing, Zentiva Group

        "Very informative and memorable training course for me."
        Quality Vice President, Darou Pakhsh

        "The trainer was very knowledgeable about the topics and was able to answer all questions."
        Drug Product Subject Matter Expert, Pfizer

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