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 08/05/2023. 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: Henri Caplain, France; Jan de Hoon, Belgium

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
Emma Smith, 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
Harun Badakhshi, 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

16:45 – 17:15

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 assess risk from pre-clinical to clinical research more efficiently | Experiences and suggestions

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

09:00

The pre-clinical perspective
Stephanie Plassmann, Germany

09:35

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

6 Selected Short Presentations
10 minutes (presentation) + 5 minutes (discussion),
Election of the Winning Short Presentation and Poster

14:00

Early clinical proof of effect of inhaled lung therapies in Phase 1 : Evaluation of mode of action and drug deposition in the target organ of healthy subjects
Johannes H. Nagelschmitz

14:15

Can TRPA1-Antagonists Solve The Unmet Medical Need For Chemotherapy-Induced Peripheral Neuropathy?
Heleen Marynissen

14:30

Optimising paediatric medicines development through early selection of the best accepted formulation with a scientifically sound composite endpoint method
Viviane Klingmann

14:45

Piloting new patient centric sampling approaches in phase-1 clinical trials 
Jorien Gilops

15:00

Healthy Volunteers in Distress: Creating A Guideline For Implementation Of Emergency Mock Trainings In A Phase I Clinical Pharmacology Unit
Thomas De Ridder

15:15

Feasibility Assessment Of The BD Rhapsody™ Single-cell RNA-sequencing Platform On Liver Fine-needle Aspirates And Blood Of Healthy Volunteers
Jonathan Janssens

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; Jelena Curcic, Switzerland
Digitalisation in early clinical trials: theory and practical examples
Sverre Bengtsson, Sweden

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

17:30 - 20:00

GET-TOGETHER

17:45

Welcome by the EUFEMED President and the AGAH President

17:30

Meet & Greet at the Ground Floor

18:30

AFPT 30th Birthday celebration: Speech by Henri Caplain, Preisdent AFPT

19:15

Award Ceremony

Meet & Greet

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; Joachim Höchel, Germany

09:00

POM – It is all about proof of mechanism

Fabienne Schumacher, 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; Joachim Hoechel, Germany

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

Emma Meijer, The Netherlands

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

Preliminary

Programme >>

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