BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//AGAH - ECPv5.16.4//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:AGAH
X-ORIGINAL-URL:https://dev.agah.eu
X-WR-CALDESC:Veranstaltungen für AGAH
BEGIN:VTIMEZONE
TZID:Europe/Berlin
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20180325T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20181028T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;VALUE=DATE:20180228
DTEND;VALUE=DATE:20180301
DTSTAMP:20260929T022231
CREATED:20190510T112534Z
LAST-MODIFIED:20190606T083406Z
UID:2070-1519776000-1519862399@dev.agah.eu
SUMMARY:AGAH Workshop beim German Pharm Tox Summit 2018
DESCRIPTION:First-in-human trials – what you need to know.\n28.2.2018 in Göttingen\n\n\n\n\nIntroduction\n\nThis workshop addresses young scientists working in basic pharmacological research and other colleagues involved in biomedical research who would like to know more about early phase clinical development. First-in-human trials will be the focus of this workshop. Non-clinical prerequisites\, ethical and regulatory requirements\, starting dose\, dose escalation rules and stopping criteria\, design aspects and clinical conduct\, as well as pros and cons of integrated protocols will be addressed. \nDiscuss state-of-the art features of FIH trials with non-clinical and clinical experts. Breaks present a good opportunity to network with faculty and colleagues. The number of participants is limited to 50 persons. Participation fee is 40 Euro for delegates fully registered for the GPTS and 75 Euro for a day ticket for the AGAH Workshop only. \n\n\n\n\n	Morning Session \nChairs: Georg Wensing\, Wuppertal; Kerstin Breithaupt-Grögler\, Frankfurt\n\n\n\n 09:00\nWelcome and Introduction\nGeorg Wensing\, Wuppertal\n\n\n09:05 – 09:30\nWhat is a first-in-human trial and what is so special about it?\nJens Rengelshausen\, Aachen\n\n\n09:30 – 10:00\nSetting the stage: The revised EMA Guideline on early phase clinical trials\nKerstin Breithaupt-Grögler\, Frankfurt\n\n\n10:00 – 10:45\nWhich answers do we need from non-clinical pharmacology and toxicology prior to the first human exposure?\nStephanie Plassmann\, Basel\n\n\n10:45 – 11:45\nBreak for plenary lecture GPTS\n\n\n11:45 – 12:15\nNetworking lunch break\n\n\n\n\n\n\n\n	Afternoon session \nChairs: Jens Rengelshausen\, Aachen; Barbara Schug\, Oberursel\n\n\n\n12:15 – 13:00\nHow to derive the human starting dose?\nStephanie Plassmann\, Basel\n\n\n13:00 – 13:45\nIntegrated protocols: The art of combining several questions into one well-designed trial\nChristian Friedrich\, Wuppertal\n\n\n13:45 – 14:30\nClinical conduct of a first-in-human trial\nWolfgang Timmer\, München\n\n\n14:30 – 14:45\nBreak\n\n\n14:45 – 15:30\nChallenges in the ethical approval of FIH trials \nIgnaz Wessler\, Mainz\n\n\n15:30 – 16:15\nDose escalation and stopping rules in single and multiple ascending dose parts of a FIH trial\nFrank Donath\, Erfurt\n\n\n16:15 – 17:00\nWrap-up and case study ‘First-in-human trials in healthy volunteers – a ten years review‘\nGeorg Wensing\, Wuppertal\n\n\n17:00\nEnd of Workshop \nChairs: Jens Rengelshausen\, Aachen; Barbara Schug\, Oberursel\n\n\n\n12:15 – 13:00\nHow to derive the human starting dose?\nStephanie Plassmann\, Basel\n\n\n13:00 – 13:45\nIntegrated protocols: The art of combining several questions into one well-designed trial\nChristian Friedrich\, Wuppertal\n\n\n13:45 – 14:30\nClinical conduct of a first-in-human trial\nWolfgang Timmer\, München\n\n\n14:30 – 14:45\nBreak\n\n\n14:45 – 15:30\nChallenges in the ethical approval of FIH trials \nIgnaz Wessler\, Mainz\n\n\n15:30 – 16:15\nDose escalation and stopping rules in single and multiple ascending dose parts of a FIH trial\nFrank Donath\, Erfurt\n\n\n16:15 – 17:00\nWrap-up and case study ‘First-in-human trials in healthy volunteers – a ten years review‘\nGeorg Wensing\, Wuppertal\n\n\n17:00\nEnd of Workshop \nChairs: Jens Rengelshausen\, Aachen; Barbara Schug\, Oberursel\n\n\n\n12:15 – 13:00\nHow to derive the human starting dose?\nStephanie Plassmann\, Basel\n\n\n13:00 – 13:45\nIntegrated protocols: The art of combining several questions into one well-designed trial\nChristian Friedrich\, Wuppertal\n\n\n13:45 – 14:30\nClinical conduct of a first-in-human trial\nWolfgang Timmer\, München\n\n\n14:30 – 14:45\nBreak\n\n\n14:45 – 15:30\nChallenges in the ethical approval of FIH trials \nIgnaz Wessler\, Mainz\n\n\n15:30 – 16:15\nDose escalation and stopping rules in single and multiple ascending dose parts of a FIH trial\nFrank Donath\, Erfurt\n\n\n16:15 – 17:00\nWrap-up and case study ‘First-in-human trials in healthy volunteers – a ten years review‘\nGeorg Wensing\, Wuppertal\n\n\n17:00\nEnd of Workshop\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n	Language \nEnglish\n\n\n\n\n	Registration \nwww.gpts-kongress.de/programme/agah-workshop/ \n\n\n\n\n	Downloads \n20180228_FIH_JR \nDose_escalation_and_stopping_rules_in_single_and_dth \nFirst_in_man-Goettingen-28-2-2018-Wessler.pdf \nGPTS_2018_Clinical_conduct_of_a_first-in-human_trial__Timmer_ \nIntegrated_protools_AGAH_CFriedrich
URL:https://dev.agah.eu/event/agah-workshop-beim-german-pharm-tox-summit-2018/
LOCATION:Pharm Tox Summit 2018\, Göttingen\, Deutschland
CATEGORIES:Workshops
END:VEVENT
END:VCALENDAR