EFGCP Annual Conference 2018
Collaboration, Complexity and Compliance: Options for System Re-design to Master the Human Factor and Risk Management?
Description
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.
Programme
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 |
14:00 |
BREAK-OUT SESSIONS |
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) |
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 |
11:00 |
BREAK-OUT SESSION: WORKSHOPS 4-5-6 |
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 |