Contact Person
    Nicole Mastrell

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

    PHARMACOVIGILANCE DOCUMENTS IN THE LIFE CYCLE OF A MEDICINAL PRODUCT: DSUR, RMP, PSUR/PBRER, AND ADDENDUM TO THE CLINICAL OVERVIEW

    From patients to health authorities: data collection, signal management, document preparation, authority assessment

    This course gives an overview of the pharmacovigilance activities and the related documents throughout the life cycle of a medicinal product. After an introduction on benefit-risk analysis, signal management, and data collection process, the presentations will focus on regulatory, format and content requirements of the main pharmacovigilance documents. While the course is based on the EU requirements, a few relevant insights about the most relevant local requirements will be provided. The participants will learn how to plan and manage documents in the life cycle and how to address selected challenges of document preparation.

    Date: 24-25 September 2019
    Time: 09:00 am – 6:00 pm
    Venue: Barcelona, Spain
    Cost: Early bird: € 1670* (until 27-08-2019)
                Ordinary: € 1880*
                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