EFGCP - QMS Bootcamp 2027

Core principles of an Effective Quality Management System (QMS)

Description

Event Training
Type Virtual Event
Language English
Date(s) 08/01/2027
Day(s) 6 Day(s)
Duration 1 Hour/Day

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 7th of December 2026, all registered delegates will be informed and reimbursed in full.

Minimum Number of Participants: 8
Maximum Number of Participants: 18

Programme

Week 1: Friday 08 Jan 2027 - Introductions & Welcome
CEST
14:00 Session Start
Introduction to the bootcamp and Quality Management Systems, QMS
Introductions
Objectives, ways of working and house rules for the workshop
Q&A and homework for next session
15:00 Session End
Week 2: Monday 11 Jan 2027 - Building Blocks of Clinical Quality Management Systems
CEST
14:00 Session Start
Governance
Controlled Documents (Policies, SOPs)
Documents Management
Role-based training
Risk-Management
Case discussion
Q&A and what did we learn, any golden rules?
15:00 Session End
Week 3: Friday 15 Jan 2027 - Operational guidance
CEST
14:00 Session Start
Establishing the framework for operation and compliance of the quality system
Case discussion
Q&A and what did we learn, any golden rules?
15:00 Session End
Week 4: Friday 18 Jan 2027 - Continuous improvement
CEST
14:00 Session Start
How do we improve our quality management system over-time?
How is risk management integrated in this process?
Continuous improvement
Case discussion
Q&A and what did we learn, any golden rules?
15:00 Session End
Week 5: Friday 22 Jan 2027 - Safety reporting requirements
CEST
14:00 Session Start
Legal ways to adapt safety reporting
Mechanisms to oversee safety
Case discussion
Q&A and what did we learn, any golden rules?
15:00 Session End
Week 6: Friday 25 Jan 2027 - Strategies for Effective Quality management
CEST
14:00 Session Start
Quality Culture
Controlled Documents aligned with Regulations
Risk-Based Approach
Data Integrity
Technologies and Automation
Case discussion
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…
15:00 Session End