EFGCP - QMS Bootcamp 2025
Core principles of an Effective Quality Management System (QMS)
Description
Hospitals and other academic institutions are sponsoring more and more clinical trials. These trials may be multi-centre, multinational or interventional. It is important that organisations (chief investigators or Hospitals’ clinical trial centres) have a quality management system in-place when sponsoring interventional clinical trials.
This academic Quality Management System Bootcamp is developed to support people who are involved in setting up or managing a QMS that covers the conduct and overall management of clinical trials in risk-proportionate ways. The Bootcamp will include six 1-hour online sessions (via TEAMs) with a focus on the fundamentals of an effective Quality Management System. Each session will be interactive and give your quality mindset a robust workout on the practicalities of implementing quality in clinical trials. The sessions are developed and hosted by three quality professionals with expertise in Quality Management System requirements and experience in (academic) clinical research.
Though the primary focus is on academic clinical Quality Management System, the Bootcamp could also be of interest to those who manage quality within a small-sized Clinical R&D unit.
A minimum number of registrants is necessary to run this course. As soon as the threshold is reached, all registered participants will be informed that the course is confirmed on this page. Should the minimum of participants not be reached by the 21st of February 2025, all registered delegates will be informed and reimbursed in full.
Minimum Number of Participants: 8
Maximum Number of Participants: 18
Programme
| 14:00 |
Session Start |
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Introduction to the bootcamp and Quality Management Systems, QMS |
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Introductions |
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Objectives, ways of working and house rules for the workshop |
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Introduction to a clinical QMS and next sessions |
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Q&A and homework for next session |
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| 15:00 |
Session End |
| 14:00 |
Session Start |
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Governance |
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Controlled Documents (Policies, SOPs) |
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Documents Management |
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Role-based training |
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Risk-Management |
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Case discussion |
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Q&A and what did we learn, any golden rules? |
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| 15:00 |
Session End |
| 14:00 |
Session Start |
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Establishing the framework for operation and compliance of the quality system |
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Case discussion |
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Q&A and what did we learn, any golden rules? |
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| 15:00 |
Session End |
| 14:00 |
Session Start |
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How do we improve our quality management system over-time? |
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How is risk management integrated in this process? |
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Continuous improvement |
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Case discussion |
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Q&A and what did we learn, any golden rules? |
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| 15:00 |
Session End |
| 14:00 |
Session Start |
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Legal ways to adapt safety reporting |
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Mechanisms to oversee safety |
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Case discussion |
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Q&A and what did we learn, any golden rules? |
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| 15:00 |
Session End |
| 14:00 |
Session Start |
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Quality Culture |
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Controlled Documents aligned with Regulations |
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Risk-Based Approach |
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Data Integrity |
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Technologies and Automation |
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Case discussion |
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Q&A and close out/conclude on the course effectiveness to support Participants in understanding/developing the basic fundamentals of a QMS.
Provide 10 golden rules & interesting tools/links… |
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| 15:00 |
Session End |