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

29 August 2023

Event date: 29/08/2023 Export event

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 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)

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

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