drug device combination products regulatory quality requirements

    Drug-Device Combination Products: Quality & Regulatory Requirements

    13 – 15 February 2023, live online training

    Summary

    The challenges associated with drug-device combination products are complicated as they must be registered either as pharmaceutical or medical device products. This course will help you navigate this complicated regulatory landscape. You will return with an understanding of the complex regulatory landscape as it applies to your drug/device combination, including risk management, clinical considerations, and design control.

    Learning Objectives

    • Understand the regulatory requirements for drug-device, device-drug combinations
    • Gain an understanding of the roles of Competent Authorities and Notified Bodies
    • Examine best practices for working with medical device suppliers and manufacturers
    • Engage new stakeholders and establish new processes
    • Establish a control strategy to deliver safe and efficacious products
    • Understand design control expectations

    Key Topics

    • Key definitions
    • Regulatory update & pathway (EMA & FDA)
    • Notified Body (NB) Review Process
    • General Safety & Performance Requirements (GSPR)
    • Labeling
    • Quality management systems
    • Post-market surveillance

    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
    • Production

    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 30 days
    • Training in digital format
    • Digital and LinkedIn certificates

    Trainers

    Health Sciences and Medical Devices Consultant
    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: 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.

    ONLINE PARTICIPATION
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 1 822 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 30 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
    • Start Date
      13. February 2023
      09:00 AM Vienna time
      08:00 AM London time
      03:00 AM New York time
      12:00 AM Los Angeles time
    • End Date
      15. February 2023
    What participants said about this course

    "James is very competent and has the complete knowledge of the matter."
    Senior Process Expert, B. Braun

    "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."
    Tech Transfer Lead, Novartis

    "There were many areas related to EU MDR, NBOp that were completely new to us, this program helped us in understanding this better."
    External Manufacturing Management, Ferring