Agenda van de ACRON

De ACRON is de branchevereniging van CRO’s in Nederland. Wij behartigen de collectieve belangen van de aangesloten bedrijven (leden). Dit doen we door middel van het organiseren van bijeenkomsten, zowel besloten als open, netwerk en lobby activiteiten met als voornaamste doel om Nederland als onderzoeksland optimaal te laten functioneren. Bekijk hieronder de agenda van evenementen van de ACRON en Contract Research Organisaties (CRO’s) in Nederland:

Evenement details:

  • ma
    21
    sep
    2020

    EMA Clinical Trial Information System Webinar: Dynamic Demo of Sponsor Workspace

    13:00 - 17:30Online event

    Overview
    This webinar provides a demonstration of the current status of the Clinical Trials Information System (CTIS) which is currently under development, combining presentations and discussions
    on the underlying principles and concepts with demonstrations of specific functionalities.

    After a brief introduction and overview of CTIS, the workspace functionalities that are specifically designed for use by clinical trial sponsors, including commercial and noncommercial (academic) sponsors will be demonstrated.
    Following, the user roles, their hierarchy, and related permissions as well as access policies of users will be presented and how to manage these in the system.
    Functionalities for creating and managing a clinical trial application in CTIS will be outlined, and some practical advice as to how the system will be able to support users to manage their daily work and workload planning will be shared.
    Presentations will be provided by system experts complemented by pre-recorded demonstrations of the system, and rounded up in a live Q&A.

    Key Topics
    Brief introduction to the Clinical Trials Information System (CTIS)
    Access management
    Sponsor user management – principles and concepts
    Role matrix - principles, concepts and sponsor roles
    CTIS Sponsor workspace
    General overview
    Sponsor user administration in CTIS
    Clinical Trial Application management step by step
    Tools for user workload overview and management
    Preparations for CTIS Go-Live
    Current status and future master trainer involvement

    Who Should Attend
    Clinical trial sponsor staff representing commercial sponsors such as pharmaceutical companies
    and CROs, SMEs, non-commercial sponsors including academia, research institutions. CTIS
    Stakeholder associations representatives. Expert trainers with an interest in the area of Clinical
    Trials

    More information can be found at the EMA website

Contact

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