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X-ORIGINAL-URL:https://dev.agah.eu
X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20190331T010000
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DTSTART:20191027T010000
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20191111
DTEND;VALUE=DATE:20191112
DTSTAMP:20260929T015801
CREATED:20190416T190343Z
LAST-MODIFIED:20201114T160038Z
UID:2138-1573430400-1573516799@dev.agah.eu
SUMMARY:AGAH Diskussion Forum 2019
DESCRIPTION:How to interprete an investigator's brochure for meaningful risk assessment \nVeranstaltungsort: GSI\, Bonn \n\n\n\n	CONTENT \nThe 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. \n\n\n\n\n	Program \nAGAH_discussions_Forum_NOV19 \n\n\n\n\n	VENUE \nGSI - Gustav Stresemann Institut Bonn\nLanger Grabenweg 68\n53175 Bonn\nWeb: www.gsi-bonn.de \n\n\n\n\n	REGISTRATION \nCSi Hamburg GmbH\nGoernestraße 30\n20249 Hamburg\nphone: +49 40 30770300\nfax: +49 40 30770301\ne-Mail: agah-meetings@csihamburg.de \nRegistration_Form_AGAH_Workshop2019 PDF \nAnmeldeform_AGAH_Workshop_Diskussionsforum2019 PDF \n\n\n\n\n	CONTACT  \nArbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH) e. V.\nOffice: Goernestraße 30\n20249 Hamburg\nPhone: +49 40 30772097 E-Mail: info@agah.eu Web: www.agah.eu \n\n\n\n\n	FACULTY  \nDr. Kerstin Breithaupt-Grögler\n-kbr- clinical pharmacology services\, Frankfurt/Main \nDr. Frank Donath\nSocraTec R&D GmbH\, Erfurt \nDr. Katharina Erb-Zohar\nclinphase\, Hanau \nProf. Dr. Joop van Gerven\nCHDR\, Leiden/NL \nDr. Karin Göhler\nAGAH Regent\, Aachen \nProf. Dr. Jörg Hasford\nArbeitskreis medizinischer Ethik-Kommissionen\, Munich \nDr. Sarah Heil\nBundesinstitut für Arzneimittel und Medizinprodukte\, Bonn \nProf. Dr. Gerd Mikus\nClinical Pharmacology and Pharmacoepidemiology\, University Hospital\, Heidelberg \nDr. Stephanie Plassmann\nPreClinical Safety Consultants\, Basel/CH \nDr. Jens Rengelshausen\nGrünenthal GmbH\, Aachen \nN N\nPaul-Ehrlich-Institut\, Langen \nDr. Claudia Riedel\nBundesinstitut für Arzneimittel und Medizinprodukte\, Bonn \nProf. Dr. Hildegard Sourgens\nConsultant\, Munich \nDr. Elke Stahl\nBundesinstitut für Arzneimittel und Medizinprodukte\, Bonn \nPD Dr. Thomas Sudhop\nBundesinstitut für Arzneimittel und Medizinprodukte\, Bonn \nDr. Lutz Wiesner\nBundesinstitut für Arzneimittel und Medizinprodukte\, Bonn \nProf. Dr. Georg Wensing\nBayer AG\, Wuppertal \n\n\n\n\n	ORGANISATION \nWorkshop Fee \n400 € Non-Member \n300 € Member of AGAH | EUFEMED and DGKliPha or young scientistics until the age of 30 years \n100 € Member of Regulatory Agencies and ethics commission \nDelegate number is limited to 70 persons. \nFinal Registration: November 1\, 2019 \n\n\n\n\n	PRESENTATIONS \nAGAH_Disc.forum_Donath \nAGAH_Disc.forum_Erb-Zohar \nAGAH_Disc.forum_Hasford \nAGAH_Disc.forum_Plassmann_Wiesner \nAGAH_Disc.forum_Sudhop \nAGAH_Disc.forum_vanGerven \n 
URL:https://dev.agah.eu/event/agah-diskussionsforum-2019/
LOCATION:GSI\, Bonn\, Deutschland
CATEGORIES:Workshops
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