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

Subject to change without notice,  Status 07/03/2023. Please click on the plus + for more content.

Pre-Conference Workshop

Wednesday, May 24, 2023

13:00 - 18:00

Conducting human challenge trials: COVID-19 and beyond…

Chairs:

13:00 – 13:10

Welcome
Henri Caplain, France

13:10 – 13:25

General introduction: Challenge studies, what’s in a name?
Jan de Hoon, Belgium

13:30 – 13:55

Challenge studies with infectious agents
Malick Gibani, United Kingdom

+ 10 min Q&A

14:05 – 14:30

Challenge studies with infectious agents: pro, cons and ethical aspects
Hugh Davies, United Kingdom

+ 10 min Q&A

14:40 – 15:05

Challenge studies in asthma
Frank-Dietrich Wagner, Germany

+ 10 min Q&A

15:15 – 15:45

Break

15:45 – 16:10

Challenge studies with immunological stimulants
Matthijs Moerland, The Netherlands

+ 10 min Q&A

16:20 – 16:45

Challenge agents in target engagement models
Jan de Hoon, Belgium

+ 10 min Q&A

16:55 – 17:20
(remote presentation)

Challenge studies in pain: the pleasure of applying pain…
Philippe Danjou, France

+ 10 min Q&A

17:25 – 18:00

General discussion and closing remarks

Day 1 - Thursday, 25 May, 2023

08:00

Registration

08:45

Welcome and Introduction by the President
Tim Hardman, UK

 

Session 1
09:00 - 10:30

How to establish a sound basis for human risk assessment

Chairs: Jan de Hoon, Belgium; Rob Zuiker, The Netherlands

09:00

The pre-clinical perspective
Stephanie Plassmann, Germany

09:25

The ethics review perspective
Joop Van Gerven, The Netherlands

09:50

The clinical perspective
Henri Caplain, France

10:15

Moderated plenary discussion with the speakers        

10:30

Break

Session 2
11:00 - 12:30

Challenges in healthy volunteers and patient recruitment for human pharmacology trials - Experiences and Suggestions

Chairs: Izaak den Daas, The Netherlands; Yves Donazzolo, France

11:00

Studies in healthy volunteers: Evolution in recruitment of healthy volunteer trials, before, during and after the pandemic

Jelle Klein, Belgium

 

Main challenges for the inclusion of patients in phase I trials

Izaak den Daas, The Netherlands

 

„Why I took part in a clinical trial“ – Results from a motivation survery amongst Polish healthy volunteers

Agnieszka Kulesza, Poland

 

Ethical challenges in recruitment for phase I trials

Yves Donazzolo, France

11:45

Moderated plenary discussion with the speakers: 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, Germany;  Erik Mannaert, Belgium

14:00

6 Selected Short Presentations,

Election of the Winning Short Presentation and Poster

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: Sybille Baumann, Germany; Henri Caplain, France

16:00

Nextgen endpoints for clinical drug development
Kristin Hannesdottir, United States
Handling of digital endpoints
tba

16:40

Moderated plenary discussion

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

Social Event with celebration of 30th Anniversary of AFPT

Day 2 - 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, UK; Andreas Kovar, Germany

09:00

POM – It is all about proof of mechanism

Fabienne Schuhmacher, Germany

09:20

From Celecoxib to Gene Editing – Experiences of a London based first in human principal investigator

Jörg Täubel, UK

09:40

Fair consent processes in early phase research – striking a balance between benefits and harms

Hugh Davies, UK

10:00

Moderated plenary discussion

10:30

Break

Session 6
11:00 - 12:00

None fits all: (adaptive) scientific advice formats in the (innovative) pharmaceutical development process - Experiences and Suggestions

Chairs: Ingrid Klingmann, Belgium; Dick de Vries, The Netherlands

11:00

Presentation of the new regulatory support toolbox for early (clinical) development and beyond

Bettina Ziegele, Germany

11:30

Moderated plenary discussion: How can these options best be used for innovative early pharmaceutical medicines development by academia, large and small pharma companies?

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, UK; Jelle Klein, Belgium

13:30

How can CROs support big pharma as well as small biotech companies in their CTR submission

Sybille Baumann, Germany

 

Sponsor and CTU communication during the dossier preparation and trial authorisation process – Experiences from sponsor and site perspectives

tba

14:15

Moderated plenary discussion    

15:00

Closing Remarks and Farewell from the President Elect

Jan de Hoon, Belgium

15:10

End of the Conference

Conference days

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