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 the time shown below in each timezone. 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.

eCF Members -- FOLLOW THIS LINK TO REGISTER:    eCF Focus Session: EMA Computerised Systems Guideline (eclinicalforum.org)

Not an eCF member? Please review our membership info at Membership (eclinicalforum.org)