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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 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

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

 

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eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

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eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

Read more
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eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

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