4th EUFEMED Conference

25-26 May 2023 - Berlin (Germany)

Mastering the New Time Pressure on Human Pharmacology

Focused strategies based on lessons learned in the pandemic

LOGIN CONFERENCE SYSTEM

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.

Pre-Conference Workshop,

Wednesday, May 24, 2023

13:00-18:00

The challenges in conducting human challenge trials: from COVID-19 and beyond…
Chairs:         

Thursday, 25 May, 2023

08:00

Registration

08:45

Welcome and Introduction by the President
Tim Hardman

 

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 Zuiker 

09:00

Introductory presentation from toxicologist and human pharmacologist point of view:

  • How much pre-clinical work is really needed (individualization vs. one-size-fits-all?) and which level of risk can be moved to the trial subjects?
  • The role of the IB for de-risking FiM studies

 

09:45

Moderated plenary discussion with the speakers        

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 Täubel 

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

Moderated plenary discussion

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  

17:30

End of Day 1

Social Event with celebration of 30th Anniversary of AFPT

Friday, 26 May, 2023

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, HEALIXIA 

14:00

Moderated plenary discussion    

15:00

Closing Remarks and Farewell from the President Elect

15:10

End of the Conference

Conference days
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