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2022 ISPE Europe Annual Conference

EU22CEAPR1/SES303 - The Role of Computerized eClinical Systems & Data within the Sponsor-Supplier-Investigator Triangle


Apr 27, 2022 8:30am ‐ Apr 27, 2022 9:10am


Description

A lot has happened in the last two years, including: • EMA Notice to sponsors dated April 2020 (EMA/INS/GCP/467532/2019) • EMA GCP Q&A Good Clinical Practice (Question 8/9) in 2021 • EMA IWG Draft guidance dated 10 June 2021 (EMA/226170/2021) Additionally, the E6(R3) EWG is currently working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) and the COVID Pandemic has had a significant impact on GCP processes by requiring more remote and decentralized solutions for patients, CROs and sponsors. Therefore, there is a need to address what has already been defined and published by the regulators as well as to look at the upcoming changes pertaining to the quality of GCP systems. The GAMP Good Practice Guide “Enabling Innovation” of 2021 and the GAMP Good Practice Guide “Validation and Compliance of Computerized GCP Systems and Data” of 2017 provide up-to-date guidance to efficiently create valuable validation documentation to meet current and future GCP expectations, including data integrity, critical thinking, state-of-the-art technology and project and validation methodology.

Speaker(s):

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