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 firstname.lastname@example.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.