Introduction

The primary objective of the Investigator’s Brochure (IB) in a Phase 1 trial is to serve the responsible investigator for reliable benefit-risk assessment, however, experience teaches us that it is mostly viewed and written as a Clinical Trial Authorisation document. The PI’s need to fully understand the implications of the translational study results in order to decide on the required risk mitigation steps to be taken in the interest of participant protection, is not reliably implemented in the current practice.

Help us to create a more meaningful IB process for translational results interpretation, investigator-centred presentation and decision-making in this Workshop on developing the IB in line with all existing and upcoming international requirements but focusing on the needs in early phase trials. Based on the results from this Workshop EUFEMED will prepare a guideline for public consultation and final publication.

In the final discussion the opinions of the participants will be collected in anonymized polls.

Programme

Friday, 20 September 2024

08:00 - 09:00
Registration
09:00 - 09:10
Welcome and Introduction
Jan de Hoon, Prof. Dr.
Jan de Hoon, Prof. Dr.
UZ Leuven, Belgium
09:10 - 09:40
What does the PI of an early phase clinical trial need from an Investigator’s Brochure?
Jeroen van Smeden
Jeroen van Smeden
CHDR, Netherlands
09:40 - 10:10
What does a Regulator authorizing an early phase clinical trial need from an Investigator’s Brochure?
Sandrine Tinton, PhD
Sandrine Tinton, PhD
AFMPS, Belgium
10:10 - 10:40
What are the challenges of pre-clinical and translational experts in interpreting, risk-assessing and explaining the so far existing results?
Daniela Guckelberger, DVM, PhD
Daniela Guckelberger, DVM, PhD
PCS, Switzerland
10:40 - 11:00
Coffee Break
11:00 - 12:15
Breakout sessions I
Session 1
Preclinical Aspects: e.g., what data need to be included, how to present this data, risk benefit for first-in-human.
Stephanie Plassmann, DVM, PhD
Stephanie Plassmann, DVM, PhD
PCS, Switzerland
Thijs van Iersel, MD
Thijs van Iersel, MD
ICON, Netherlands
Session 2
Clinical / life cycle IBs: e.g., update of IB during drug cycle, how to keep the IB understandable and ´short´, updates of risk-benefit, substantial amendments.
Henri Caplain, MD, MSc
Henri Caplain, MD, MSc
, France
Nariné Baririan, PhD
Nariné Baririan, PhD
Chiesi, Italy
Session 3
Regulatory Aspects: e.g., what is needed for correct reviews, how to present data clearly, when to make amendments, input from different countries.
Sandrine Tinton, PhD
Sandrine Tinton, PhD
AFMPS, Belgium
Ingrid Klingmann, MD, PhD
Ingrid Klingmann, MD, PhD
Pharmaplex, Belgium
Caludia Riedel, PhD
Caludia Riedel, PhD
BfArM, Germany
Session 4
Investigator / end-user Aspects: e.g., needs for interpreting safety of participants, difference early / late phase investigators
Yves Donazzolo, MD
Yves Donazzolo, MD
Eurofins Optimed, France
Jeroen van Smeden
Jeroen van Smeden
CHDR, Netherlands
Ronald Koning MD, NP
Ronald Koning MD, NP
Biokinetica, Poland
12:15 - 13:00
Lunch Break
13:00 - 14:00
Breakout sessions II
Session 1
Preclinical Aspects: e.g., what data need to be included, how to present this data, risk benefit for first-in-human.
Stephanie Plassmann, DVM, PhD
Stephanie Plassmann, DVM, PhD
PCS, Switzerland
Thijs van Iersel, MD
Thijs van Iersel, MD
ICON, Netherlands
Session 2
Clinical / life cycle IBs: e.g., update of IB during drug cycle, how to keep the IB understandable and ´short´, updates of risk-benefit, substantial amendments.
Henri Caplain, MD, MSc
Henri Caplain, MD, MSc
, France
Nariné Baririan, PhD
Nariné Baririan, PhD
Chiesi, Italy
Session 3
Regulatory Aspects: e.g., what is needed for correct reviews, how to present data clearly, when to make amendments, input from different countries.
Sandrine Tinton, PhD
Sandrine Tinton, PhD
AFMPS, Belgium
Ingrid Klingmann, MD, PhD
Ingrid Klingmann, MD, PhD
Pharmaplex, Belgium
Caludia Riedel, PhD
Caludia Riedel, PhD
BfArM, Germany
Session 4
Investigator / end-user Aspects: e.g., needs for interpreting safety of participants, difference early / late phase investigators
Yves Donazzolo, MD
Yves Donazzolo, MD
Eurofins Optimed, France
Jeroen van Smeden
Jeroen van Smeden
CHDR, Netherlands
Ronald Koning MD, NP
Ronald Koning MD, NP
Biokinetica, Poland
14:00 - 15:30
Reports with discussion from the Break-out Sessions
Ingrid Klingmann, MD, PhD
Moderator
Ingrid Klingmann, MD, PhD
Pharmaplex, Belgium
15:30 - 15:45
Coffee Break
15:45 - 16:30
Discussion and decision on concluding recommendations for the early phase IB guideline
Jelle Klein, MD, BHS
Jelle Klein, MD, BHS
SGS, Belgium
16:30
End of the Workshop

Venue

Address

University of Warsaw
Faculty of Applied Linguistics
Dobra 55, 00-312 Warsaw, Poland

The nearest entrance from Browarna Street
Auditorium 0.410 (ground floor)

Useful information

Sightseeing

Registration

Attendance fees

Early bird fee
(until 19 July 2024)
Regular fee
(from 20 July 2024)
EUFEMED members
(AGAH, AHPPI, HEALIXIA, AFPT-Le Club Phase 1, POLFEMED)
€ 150 + VAT
€ 190 + VAT
Non-Members
€ 200 + VAT
€ 250 + VAT
Payment of the registration fee covers the cost to attend all sessions, event materials, coffee breaks, and lunch during the event. Please note that this registration fee does not cover transportation and accommodation fees.

Registration form

The invoice will be sent to you within 7 working days.

Sponsors

Contact

Organiser and responsible for the programme

EUFEMED
Square de Meeûs 35
1000 Brussels, Belgium

info@eufemed.eu
www.eufemed.eu
Registration and billing contact
KDK Sp. z o. o.
Mokotowska 14
00-561 Warsaw, Poland

eufemed@kdkevents.pl
www.kdkevents.pl

NIP: 5262837167, REGON: 140034252
KRS: 0000230249, Sąd Rejonowy dla M.St. Warszawy w Warszawie
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