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AGAH discussion Forum 2019

11. November 2019
GSI – Gustav Stresemann Institut Bonn, Bonn

How to interprete an investigator's brochure for meaningful risk assessment

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

Anmeldeform_AGAH_Workshop_Diskussionsforum2019

Registration_Form_AGAH_Workshop2019

CONTACT

Arbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH) e. V.
Office: Goernestraße 30
20249 Hamburg
Phone: +49 40 30772097
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

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