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AGAH Diskussionsforum 2019 —

11. November 2019
GSI, Bonn

 

Die Investigator’s Brochure in FIH und frühen klinischen Prüfungen

Programm und Anmeldemöglichkeit folgt

Veranstaltungsort: GSI, Bonn

CONTENT

The Investigator’s Brochure is the key document for the Sponsor to compile the pertinent knowledge on the pharmaceutical, pharmacological, and toxicological characteristics of and –if any- the clinical experience with the investigational medicinal product (IMP). Critical appraisal of potential safety risks and appropriate precautions on how to avoid putting healthy subjects or patients receiving the IMP at risk is required to provide guidance for the investigator. In first-in-human and early phase clinical trials, clinical experience with the IMP is lacking or sparse and non-clinical safety assessments must enable an adequate risk assessment to support the transition from animal models to man. This AGAH discussion forum will debate what is required from an IB to provide proper guidance for the investigator about an IMP in early clinical trials. The discussion forum addresses investigators and trial teams with some hands-on experience in early phase clinical trials. Clinicians performing first in human trials / early clinical trials in patients may equally profit from this workshop.

Venue

GSI - Gustav Stresemann Institut Bonn Langer Grabenweg 68 53175 Bonn Web: www.gsi-bonn.de

Date

11.11.2019

REGISTRATION

CSi Hamburg GmbH Goernestraße 30 20249 Hamburg Phone: +49 40 30770300 Fax: +49 40 30770301 E-Mail: agah-meetings@csihamburg.de Download_Registrationform (engl.) PDF Download Anmeldeformblatt PDF

CONTACT

Arbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH) e. V. Office Goernestraße 30 · 20249 Hamburg Phone: +49 170 7844438 E-Mail: info@agah.eu Web: www.agah.eu

FACULTY

Dr. Kerstin Breithaupt-Grögler
-kbr- clinical pharmacology services, Frankfurt/Main

Dr. Frank Donath
SocraTec R&D GmbH, Erfurt

Dr. Katharina Erb-Zohar
clinphase, Hanau

Prof. Dr. Joop van Gerven
CHDR, Leiden/NL

Dr. Karin Göhler
AGAH Regent, Aachen

Prof. Dr. Jörg Hasford
Arbeitskreis medizinischer Ethik-Kommissionen, Munich

Dr. Sarah Heil
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn

Prof. Dr. Gerd Mikus
Clinical Pharmacology and Pharmacoepidemiology, University Hospital, Heidelberg

Dr. Stephanie Plassmann
PreClinical Safety Consultants, Basel/CH

Dr. Jens Rengelshausen
Grünenthal GmbH, Aachen

N N
Paul-Ehrlich-Institut, Langen

Dr. Claudia Riedel
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn

Prof. Dr. Hildegard Sourgens
Consultant, Munich

Dr. Elke Stahl
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn

PD Dr. Thomas Sudhop
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn

Dr. Lutz Wiesner
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn

Prof. Dr. Georg Wensing
Bayer AG, Wuppertal

Morning / Afternoon Session


09:00

Registration


09:00

Welcome and Moderation

K. Breithaupt, Frankfurt/M.
H. Sourgens, München
Online Survey (Who attends this workshop?)


09:10

The Investigator’s Brochure - Key information to support early clinical trials

J. van Gerven, Leiden/NL


10:00

Deficiencies / Uncertainties in IBs - The Regulatory Authority‘s experience

E. Stahl, Bonn; N N, Langen; T. Sudhop, Bonn


10:45

Break


11:15

Guidance for the Investigator

Chair: G. Mikus, Heidelberg

View point of Sponsors Expectations from Regulatory Agency, Ethics Committee, and Investigator

F. Donath, Erfurt K. Göhler, Aachen J. Hasford, München T. Sudhop, Bonn G. Wensing, Wuppertal


12:15

Structured Open-Forum Discussion  Online Survey (Experience of the audience: How to find the relevant safety information in an IB)

J. Rengelshausen, Aachen  Online Survey (Experience of the audience: Does the IB allow a meaningful risk assessment?) K. Göhler, Aachen  Questions raised by the Audience


13:00

Break


13:45

Reference safety information – a key element of the

IB K. Erb-Zohar, Hanau

Online Survey (Experience of the audience: Where to find the reference safety information in the IB)

K. Erb-Zohar, Hanau; J. Rengelshausen, Aachen


14:05

Discussion

F. Donath, Erfurt K. Erb-Zohar, Hanau G. Mikus, Heidelberg E. Stahl, Bonn G. Wensing, Wuppertal


14:30

Potential risks for human subjects associated with inadequate non-clinical safety assessment

S. Plassmann, Basel/CH; L. Wiesner, Bonn


15:00

Discussion

S. Plassmann, Basel/CH J. van Gerven, Leiden/NL L. Wiesner, Bonn NN, Langen

 


15:30

Break


15:45

Case study presented by J. van Gerven, Leiden:

Integrating data from the IB – a new tool for translational integration of preclinical effects


16:45

Wrap-up


17:00

End of Workshop

ORGANISATION

Workshop Fee

400 € Non-Member

300 € Member of AGAH | EUFEMED and DGKliPha or young scientistics until the age of 30 years

100 € Member of Regulatory Agencies and ethics commission

Delegate number is limited to 70 persons.

Final Registration: November 1, 2019

11. November 2019

AGAH Diskussionsforum 2019 —

GSI


Bonn
Deutschland