EFGCP Annual Conference 2018

Collaboration, Complexity and Compliance: Options for System Re-design to Master the Human Factor and Risk Management?


Event Conference
Type Face To Face
Language English
Date(s) 20 & 21 Feb. 2018
Day(s) 2 Day(s)
Duration 8 hours/ day

For 24 years, EFGCP has united the interests of researchers, patients, sponsors, competent authorities and ethicists in clinical research. Over that time, the research environment has become increasingly complex to navigate while facing ever-changing global regulations and guidance. While technological developments can help us to manage complexity and improve compliance, they come with their own challenges and there is still much to be done on the third vital element: the “Human Factor” in clinical research. EFGCP is therefore dedicating the 2018 Annual Conference to the consideration of challenges we all face, while identifying strategies with which to keep our research compliant and efficient. Though we may compete with each other, our interests in furthering clinical development are held in common. We can all gain from collaboration. Working in a corner is no longer pragmatic for any of us: mutually beneficial collaboration is the only way to succeed. Speakers at this conference come from all aspects of clinical research, including those who inspect on behalf of our governments.
Every speaker has the mission to help delegates remain in compliance, while optimising our research strategies to achieve trial outcomes acceptable from all viewpoints. This conference is known for describing and defining challenges, while deliberating creative solutions. The conference includes Plenary Sessions to discuss systematic approaches as well as Workshops which have been found highly effective in identifying real-world solutions.
We invite you to discuss these challenges, and their solutions, with colleagues old and new in Brussels.


Tuesday 20 February 2018
8:15 Introduction & Welcome Coffee
09:00 Welcome to the Conference
Plenary Session 1: Setting the Scene
09:05 Key Note Presentation: Current level of compliance that inspectors find, expected trends and developments
09:25 Pros and cons, needs and challenges of complex protocols
09:45 Leadership, team work and communication: systematic impact on the human factor
10:05 Questions & Discussion
11:00 Coffee Break
Plenary Session 2: How can our current quality framework help us to manage complexity, compliance and collaboration more efficiently?
11:30 Will ICH-E6(R2) be help or hinderance for improving clinical medicine development?
11:55 Is today’s ISO framework efficiently driving medical device trials performance?
12:20 Panel and Open Forum Discussion
13:00 Lunch
Workshop 1: Welcome to the ‘Research Ethics by Design Initiative ‘: Pulling together to build Multi-National Capacity and Credibility
Workshop 2: Vendor Oversight – Overseen or Overlooked
Workshop 3: The role of engaged patients in process improvements/protocol design
15:30 Coffee Break
16:00 Feedback from Workshops 1-2-3
Plenary Session 3: The Joseph Hoet Lecture on Ethics in Clinical Research
16:30 GCP – literally or common sense? – A personal reflection
17:00 EFGCP Annual General Meeting (for EFGCP Members)
Wednesday 21 February 2018
8:30 Introduction & Welcome Coffee
Plenary Session 4: Human Factor - The Driving Force for Good and Bad?
09:00 Take the Human Factor into account!
09:20 Questions & Discussion
09:30 Adapting processes to allow humans to perform effectively
10:25 Summary
10:30 Coffee Break
Workshop 4: International review group: when things go wrong
Workshop 5: New responsibilities of PIs as defined in ICH-GCP(R2)
Workshop 6: Revised CIOMS ethics guidelines: How they could help to manage compliance, complexity and collaboration
12:30 Lunch
13:30 Feedback from Workshops 4-5-6
Plenary Session 5: Proposals for Solutions
14:00 The patients’ potential for support to system re-design in new treatment development
14:20 New initiatives for system redesign to better manage compliance, complexity and collaboration
14:40 Optimising collaboration to maximise compliance
15:00 Compliance, complexity and collaboration – the inspector’s view
15:20 Questions & Open Forum Discussion
15:45 Summary & Conclusions from the Conference
16:00 End of the Conference