Contact Person
    Nicole Mastrell

    Event Manager & PA to CEO
    Email: nm@mva.org
    Phone: (M) +45 6141 8634
    Linkedin

    ESUBMISSIONS: UPDATE ON ALL TELEMATICS PROJECTS AND THE IMPACT ON REGULATORY PROCESSES AND COMPANIES

    Get informed about the latest status of all EU projects on electronic submission, ranging from eCTD, eAF, CESP, xEVMPD, SPOR and ISO IDMP

    eCTD has been implemented as the international standard for dossier submissions. In Europe eCTD is the mandatory format for submission since January 2019.

    Besides eCTD, many other eSubmission projects are ongoing, including: electronic Application Form (eAF), Common European Submission Plaform (CESP), the EMA Gateway, eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD), ISO Identification of a Medicinal Product (IDMP) and SPOR project.

    This course will explain the history, current state and outlook of these Telematics projects and impact on Industry. Moreover it will provide insight on the latest developments, from direct interactions with EMA and NCAs.

    With all these developments and ongoing activities, this course becomes a two-day master class and bring you up-to-date with all you need to know with regards to the roadmap and strategy of eSubmission and what you have to consider from an organizational point of view for your company.

    If you’re responsible for Regulatory Affairs, you might not have the time or resources to be aware of all developments, changes and update on the Telematics roadmap and impact on processes within your organization.

    To get up-to-date, this course will put the attention on what are the issues to think about for getting ready, including possible RIM (Regulatory Information Management) solutions and company requirements.

    Date: 22-23 October 2019
    Time: 09:30 am – 6:00 pm
    Venue: Barcelona, Spain
    Cost: Early bird: € 1570* (until 27-08-2019)
                Ordinary: € 1780*
                Freelance – Academy – Public Administration: € 890*
                * For Italian companies: + 22% VAT
                The fee includes: tuition, teaching materials, lunches and coffee breaks, office assistance, attendance certificate

    READ MORE & SIGN UP

    Registration offline
    Fill in the registration form (last page of the event brochure) and email it to maraclaudia.algarotti@lsacademy.com and she will process the booking at a 15% discount.

    Registration online
    Complete booking and payment at this link and use code MVA1908 to book and receive 15% off.

    CONTACT
    For any further question feel free to contact Mara Claudia Algarotti maraclaudia.algarotti@lsacademy.com