4th EUFEMED Conference
25-26 May 2023 - Berlin (Germany)
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Mastering the New Time Pressure on Human Pharmacology
Focused strategies based on lessons learned in the pandemic
25-26 May 2023 - Berlin (Germany)
Mastering the New Time Pressure on Human Pharmacology
Focused strategies based on lessons learned in the pandemic
Version October 2022; All times are in CEST
During the afternoon attendees including exhibitors can book hop-in rooms for small groups or one-on-one discussions
Draft, status 25/01/2023. Subject to change.
13:00-18:00
The challenges in conducting human challenge trials: from COVID-19 and beyond…
Chairs: Â Â Â Â Â Â Â Â
08:00
Registration
08:45
Welcome and Introduction by the President
Tim Hardman
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Session 1
09:00 - 10:30
How to handle the step from pre-clinical to clinical research more rapidly – Experiences and suggestions
Chairs: Jan de Hoon; Rob ZuikerÂ
09:00
Introductory presentation from toxicologist and human pharmacologist point of view:
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09:45
Moderated plenary discussion with the speakers       Â
10:30
Break
Session 2
11:00 - 12:30
Managing the increasing challenges in healthy volunteers and patient recruitment for human pharmacology trials – Experiences and Suggestions
Chairs: Izaak den Daas, Jörg TäubelÂ
11:00
Introductory presentations on how we do things today
Experiences in Poland
Experiences in Belgium
Experiences in France
11:40
Moderated plenary discussion: How to improve the situation?
12:30
Lunch-Break
Session 3
14:00 - 15:30
Posters and short Presentations on topics of translational pharmacology
Chairs: Kerstin Breithaupt-Grögler, Erik Mannaert
14:00
Introductory presentations
14:40
15:30
Break
Session 4
16:00 - 17:30
Increasing Digitalisation in Human Pharmacology Studies Management:
Helping or Hindering Speeding-up clinical trials? – Experiences and Suggestions
Chairs: Henri Caplain
17:30
End of Day 1
from 17:30
Get-Together
with celebration of 30th Anniversary of AFPT
and interactive Tabletop presentations of innovative tools and methods
16:00
Selected Short Presentations, Election of the Winning Presentation Â
17:30
End of Day 1
Social Event with celebration of 30th Anniversary of AFPT
Session 5
09:00 - 10:30
Innovative Trial Approaches to Move Efficiently from FiM to Patient Participants – Experiences and Suggestions
Chairs: Paul Goldsmith, Andreas Kovar
09:00
Introductory presentations
09:40
Moderated plenary discussion
10:30
Break
Session 6
11:00 - 12:00
New joint national scientific advice in early clinical development
Chairs: Yves Donazzolo, Ingrid Klingmann
11:00
Presentation of the new joint national scientific advice procedure
11:30
Moderated plenary discussion: How best to use this new option for innovative early medicines development
12:00
Lunch
Session 7
13:30 - 15:00
Ensure Efficiency of Collaboration between Sponsors and Clinical Trial Units under the Clinical Trial Regulation – Experiences and Suggestions
Chairs: Tim Hardman, Jelle Klein
15:00
Closing Remarks and Farwell form the President Elect
Jan de Hoon
13:30
Introductory presentations from sponsor and CTU perspectives
AGAH, POLFEMED, HEALIXIAÂ
14:00
Moderated plenary discussion   Â
15:00
Closing Remarks and Farewell from the President Elect
15:10
End of the Conference
CSi Hamburg GmbH
Goernestraße 30
20249 Hamburg (Germany)