ACDM Annual Meeting | March 3-5, 2024
Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen from March 3rd to 5th.
We are very pleased that Frank Henrichmann will present “How to comply with EU Guideline on computerised systems and electronic data in clinical trials” at the conference. The EMA released this regulatory guideline in 2023. It is the most extensive and detailed guidance ever published specifically for GCP systems. The EMA guideline covers key definitions and principles like Source Data, Responsibilities, and Data Integrity, along with expectations for computerized systems and their validation, including vendor management. It also covers electronic data – from data capture to audit trail review and migration – together with security expectations.
His presentation will focus on the guideline’s key topics and the challenges of adopting it.
What were the regulators’ reasons and intentions in creating this guidance?
What are the most critical changes, and how can we address them?
The main focus will be the validation of computerized systems used in clinical trials at clinical sites. He will also cover expectations for vendor oversight and collaboration, especially when using Software-as-a-Service (SaaS), and the detailed expectations for data archiving and retention.
We look forward to meeting you there and discussing technology quality management topics with you.
For more information about the ACDM Annual Meeting, click here.
