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  • eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

  • eCF Focus Session:  EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

    Date:  Tuesday, 29-August-2023      Duration: Two hours

    Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

    Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

    For This Topic:  A member from each eCF Project Team will present significant items in this guideline, from the perspective of their team topic.

    Areas of Focus:

    • AI/ML and RWE – Dave Stein, D. Bartley Consulting
    • DCT  – Wolfgang Summa, Merck KgAa
    • eConsent – Valeria Orlova, Medidata 3Ds
    • eCOA – Tom Haag, Cardinal Solutions Consulting
    • Investigator Signature – Cinzia Piccini, Eli Lilly
    • Validation – Devry Spreitzer, Astellas
    • Archiving & Decommissioning – Alan Yeomans, Viedoc
    • Audit Trail Review – Linda King, Astellas
    • eSRA (eSource) and eISF – Ronit Elshtein, Pfizer
    • REG – mapping to eCF Requirements  – Neil Konopka, Oracle

    Time – This is a TWO-HOUR Focus session, starting at UTC 1300 (0900 NYC, 1500 Brussels, 2200 Tokyo). We apologize to those who will be viewing it during a non-optimal time. We will be recording, so please also register if you want access to the recording, which will be available the day after.

  • Online registration is closed

    Please send an email to webinars@eclinicalforum.org to do last-minute registration and/or receive a link to the recording. Please send from your work email and include your location.